Hospitals point at the device; manufacturers point at technique. Without an early dual-track evidence plan, the appraisal question is written by someone else. This article explains how orthopedic implant and high-value device manufacturers should respond to fracture claims under the PRC Civil Code, including the product defect presumption, the seventy-two hour evidence preservation protocol, and the design of dual-track technical appraisals.
The structural challenge of implant fracture claims
An orthopedic implant fracture claim combines medical and technical uncertainty in a single dispute. The patient's treating hospital typically argues that the implant was defective, pointing to the fracture as evidence. The manufacturer argues that the fracture resulted from surgical technique, patient factors or excessive loading, and that the implant met its specification. Both positions can be true in part, and the legal system must allocate responsibility between the clinical pathway and the product pathway. The allocation is decided not by the closing argument but by the appraisal, and the appraisal is framed by the questions that the parties persuade the court to ask.
The difficulty for the manufacturer is that the medical harm context creates a presumption in the patient's favour. The patient who suffers a failed implant in a hospital has already been harmed in a medical setting, and the evidentiary burden on the patient is lighter than in an ordinary product liability case. The manufacturer must therefore act early, before the evidence is lost and before the appraisal question is fixed, to preserve the technical facts that support the product side of the allocation.
- Legal analysis diagram of implant fracture claims: hospital medical-damage track under Civil Code Articles 1218 and 1222 versus manufacturer product-defect track under Articles 1202 and 1203, combined by SPC Guiding Case No. 108 and dual-track appraisal allocation rather than a single exclusive theory.
- Dual-track liability map for implant fracture claims under PRC Civil Code.
- Hospital points at the device · manufacturer points at technique · appraisal allocates both
- Patient harm after implant fracture
- Counsel typically pleads both tracks → joint & several liability risk
Statutory framework
Civil Code product liability and medical damage provisions
The PRC Civil Code establishes the framework for implant claims across two tracks. Article 1202 provides that where a product is defective and causes damage, the manufacturer is liable, and Article 1203 gives the injured party the option to claim against the manufacturer or the seller. Article 1218 provides that where a patient suffers damage in diagnosis or treatment, and the medical institution or its staff is at fault, the institution bears liability. Article 1222 creates statutory presumptions of fault against the medical institution in defined circumstances, including where the institution conceals or refuses to provide the medical records, or where the records are destroyed or forged. The patient's counsel will typically plead both tracks: medical malpractice against the hospital and product liability against the manufacturer, seeking joint and several liability.
"Article 1202 of the PRC Civil Code: Where a product is defective and causes damage to another person, the manufacturer of the product shall bear tort liability."
Medical device regulations
The Regulations on the Supervision and Administration of Medical Devices, Article 88, address the manufacturer's obligations related to defective devices and the remedial measures, including notification and recall. The provision matters in the fracture claim context because the manufacturer's conduct after the fracture, including whether it investigated, notified and recalled, is examined alongside the technical cause of the fracture.
SPC judicial interpretation on medical damage
The Supreme People's Court Judicial Interpretation on Medical Damage Liability Disputes, Articles 16 through 21, sets out the evidentiary and appraisal rules for medical damage cases, including the treatment of multiple causes, the role of the medical damage appraisal and the allocation of the burden of proof between the medical and the product tracks. The interpretation is the procedural framework within which the dual-track appraisal operates.
Enforcement context: SPC Guiding Case No. 108
SPC Guiding Case No. 108 addressed the allocation of proof in a joint liability claim involving both hospital clinical negligence and manufacturer product defect. The case clarified how the court should treat the evidence of improper surgical fixation against the evidence of metallurgical fatigue failure, and how the appraisal findings on each track should be combined into a single liability allocation. The guiding case is the reference point for the dual-track approach: the court does not choose one explanation to the exclusion of the other, but allocates responsibility according to the evidence on each track. For the manufacturer, the case confirms that the product defect analysis must be supported by technical evidence that survives the appraisal, and that the absence of such evidence leads to the full allocation against the manufacturer.
The seventy-two hour evidence preservation protocol
The manufacturer's response begins within seventy-two hours of receiving notice of the fracture claim. The protocol has six components.
Secure the explant and the packaging
The explanted device is the single most important piece of evidence, and the manufacturer should secure it with a chain of custody on paper. The protocol should arrange for the retrieval of the explant from the hospital, the joint sealing of the explant and its packaging, and the documentation of the transfer. The packaging includes the implant card, the lot number, the UDI or the batch record, and the manufacturer should preserve the corresponding manufacturing records.
Pull the lot family history
The manufacturer should pull the design history, the manufacturing records, the quality control results and the complaint history for the lot family of the explanted device. The purpose is to establish whether the fracture is an isolated event or a pattern, and whether any prior complaint, CAPA or regulatory report is relevant to the claim.
Hold the IFU and training records
The version of the instructions for use that accompanied the device, and the training records for the implanting team and the hospital, should be preserved. The records establish the intended use, the contraindications and the surgical technique requirements that the hospital's argument may contradict.
Notify insurers
The manufacturer should notify its product liability insurers within the notice period required by the policy, and should coordinate the defense with the insurers' panel counsel. The notification should include the preliminary facts and the preservation steps taken, so that the insurer's coverage decision is made on a complete record.
Align hospital communication
The manufacturer should coordinate the communication with the hospital so that junior staff do not confess product fault in informal conversations. The hospital's clinical staff may speculate about the device in the patient's presence, and those statements can become the plaintiff's evidence. The manufacturer should designate a single contact for the hospital and should instruct the sales and service staff on the communication boundary.
Document every step
The preservation protocol should be documented with dates, participants and evidence of the chain of custody. The documentation is the contemporaneous record that the manufacturer acted responsibly from the first notice, and it is the foundation of the defence file.
- Flow chart from 72-hour notice protocol — secure explant, lot history, IFU and training, insurers, hospital communication, documentation — through product quality technical appraisal and medical malpractice judicial appraisal to fighting the question presented and joint-and-several contribution strategy.
- 72-hour evidence preservation and dual-track appraisal design flow for implant fracture claims.
- 72-hour preservation clock · then design the questions the court will ask
- T+0 — fracture claim notice received (start 72-hour clock)
- Secure explant + packaging
Designing the dual-track appraisal
The appraisal is the battleground of the fracture claim, and the manufacturer's objective is to influence the questions that the appraisal must answer. The protocol has two components.
Product quality technical appraisal
The product track appraisal should examine whether the implant met its specification and whether the fracture resulted from a manufacturing or design defect. The manufacturer should propose questions that separate the product performance from the clinical factors: the chemical composition and metallurgical properties of the explant, the presence of material fatigue or manufacturing discontinuity, and the comparison of the failed implant against the lot family and the design specification. The destructive testing question should be addressed expressly, because testing that destroys the only sample may prevent the medical track analysis, and the parties should agree on the testing protocol before the destruction.
Medical malpractice judicial appraisal
The medical track appraisal should examine whether the hospital's surgical technique, patient selection or post-operative care contributed to the fracture. The manufacturer should propose questions that address the surgical fixation method, the alignment and the loading conditions, and the compliance with the IFU and the training. The medical appraisal and the product appraisal should be sequenced so that the findings on each track are consistent, and the manufacturer should preserve the right to challenge the appraisal questions before they are finalized.
Fighting the question presented
The appraisal framing often decides more than the closing argument. If the court adopts a question that presumes the fracture resulted from a product defect, the manufacturer's technical defence starts at a disadvantage. The manufacturer's counsel should therefore engage with the question design at the earliest stage, propose the dual-track questions, and preserve the record of the proposal. The manufacturer should also be prepared for the joint and several liability structure: even where the hospital's fault is established, the plaintiff may still claim the full amount against the manufacturer, and the manufacturer's recovery against the hospital depends on the allocation in the appraisal and the judgment. The defence strategy should therefore protect both the liability allocation and the contribution claim.
The commercial dimension should not be forgotten. A fracture claim is also a reputational event for the product and the franchise, and the manufacturer should coordinate the legal response with the clinical communications, the customer updates and the regulatory notifications. The claim file should include the evidence preservation protocol, the appraisal questions, the expert assessments and the settlement analysis, so that the company can make the strategic decision whether to litigate or settle with the full picture in view.
Read next: Device product liability · Recalls
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