MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 36 M/+4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	75100857
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).(b)(6).
Event or Problem Description
It was reported that, during total hip replacement, a piece of a trial femoral head 36 m/+4 broke off when the surgeon was performing a trial reduction of the hip.The broken piece of plastic was retrieved from the patient's wound.Surgery was resumed, without any delay, with the same device.No further complications were reported as consequence of this problem.
Additional Manufacturer Narrative
Results of investigation: it was reported that, during total hip replacement, a piece of a trial femoral head 36 m/+4 broke off when the surgeon was performing a trial reduction of the hip.The broken piece of plastic was retrieved from the patient's wound.The device, used in treatment, was not returned for investigation.A product evaluation could therefore not be performed.As batch number was not communicated, a review of the production documentation could not be performed either.A complaint review on part level was performed for the part number in scope and similar complaints were identified.Nonetheless, this failure mode is known and the occurrence and severity is within its expected risk level as per risk management.Hence, no corrective actions are deemed necessary at this time.A thorough medical assessment could not be performed due to limited information provided.Based on the available information, it is not possible to investigate whether the reported device met manufacturing specifications upon release for distribution.A review of past corrective actions was performed.Previous investigations demonstrated that the trial femoral heads may disconnect from the stem taper intra-operatively and flaps might bend or break off.In combination with our continuous effort to improve our products, evaluations aimed at optimizing this instrument have been initiated.As stated before, the performance of the device is nonetheless within the risks, which are anticipated in the risk management documentation of the product, both in occurrence and severity.No further escalation is required.However, the continued performance of the device shall be monitored through standard post market surveillance review processes.Based on the clear complaint description, the reported failure mode of a flap breakage can be confirmed.The root cause is attributed to an insufficient design specification.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag", all devices must be inspected and controlled for proper functioning after cleaning/disinfection.Instruments should only be used in their original condition.Should the part be returned or should more information become available, the investigation will be reopened.No further actions are deemed necessary at the time.Smith+nephew will continue to monitor this device for similar issues.

• Brand Name: TRIAL FEMORAL HEAD 36 M/+4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12712276
• Report Number: 9613369-2021-00394
• Device Sequence Number: 14646328
• Product Code: LZO
• UDI-Device Identifier: 07611996121902
• UDI-Public: 07611996121902
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K132435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 75100857
• Device Catalogue Number: 75100857
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2021
• Supplement Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown