MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 32 M/+4; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Model Number	75100851
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that he fins of the trial head broke off intraoperatively and remained in the patient's body.The current state of health of the patient is unknown.
Additional Manufacturer Narrative
H3, h6: it was reported that the fins of overall 6 global femoral trial heads broke off intraoperatively and remained in the patient's body.The current state of health of the patient is unknown.The devices, which intent use is in treatment, were returned for investigation.The reported failure mode of "fracture" can be confirmed.One or more flags are broken off on every single trial head.A review of the batch record revealed no deviations from the standard manufacturing process, that could have contributed to the reported issue.A review of the risk management documentation verifies the failure mode and severity of the reported issue.For the batch in scope no additional complaint was recorded.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all devices must be inspected and controlled for proper functioning after cleaning/disinfection.After the performed investigation we assume that the devices met specification at the time of manufacturing.Previous investigations demonstrated that the trial femoral head may disconnect from the stem taper intra-operatively and flaps might break off.In combination with our continuous effort to improve our products, evaluations aimed at optimizing this instrument have been initiated.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.The continued performance of the device shall be monitored through standard post market surveillance review processes.The reported failure mode of a flap breakage can be confirmed.A relationship between device and reported event can be confirmed.The root cause is attributed to a insufficient design specification.S+n will continue to monitor these devices for similar issues.
Additional Manufacturer Narrative
H3, h6: it was reported that the fins of overall 6 global femoral trial heads broke off intraoperatively and remained in the patient's body.The current state of health of the patient is unknown.The devices, which intent use is in treatment, were returned for investigation.The reported failure mode of "fracture" can be confirmed.The provided x-rays were reviewed and confirm the reported, broken fin from the trial head that remains in the patient.A review of the batch record revealed no deviations from the standard manufacturing process, that could have contributed to the reported issue.A review of the risk management documentation verifies the failure mode and severity of the reported issue.For the batch in scope no additional complaint was recorded.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.After the performed investigation we assume that the devices met specification at the time of manufacturing.Previous investigations demonstrated that the trial femoral head may disconnect from the stem taper intra-operatively and flaps might break off.In combination with our continuous effort to improve our products, evaluations aimed at optimizing this instrument have been initiated.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.The continued performance of the device shall be monitored through standard post market surveillance review processes.The reported failure mode of a flap breakage can be confirmed.A relationship between device and reported event can be confirmed.The root cause is attributed to a insufficient design specification.S+n will continue to monitor these devices for similar issues.
Additional Manufacturer Narrative
H3, h6: it was reported that he fins of the trial head broke off intraoperatively and remained in the patient's body.The current state of health of the patient is unknown.The device, intended for use in treatment, was returned for investigation.The reported failure mode of "fracture" can be confirmed.The provided x-rays were reviewed and confirm the reported, broken fin from the trial head that remains in the patient.A review of the batch record revealed no deviations from the standard manufacturing process, that could have contributed to the reported issue.A review of the risk management documentation verifies the failure mode and severity of the reported issue.For the batch in scope no additional complaint was recorded.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.After the performed investigation we assume that the devices met specification at the time of manufacturing.Previous investigations demonstrated that the trial femoral head may disconnect from the stem taper intra-operatively and flaps might break off.In combination with our continuous effort to improve our products, evaluations aimed at optimizing this instrument have been initiated.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.The continued performance of the device shall be monitored through standard post market surveillance review processes.The reported failure mode of a flap breakage can be confirmed.A relationship between device and reported event can be confirmed.The root cause is attributed to a insufficient design specification.S+n will continue to monitor these devices for similar issues.
Additional Manufacturer Narrative
Updated results of investigation: it was reported that the fins of the trial head broke off intraoperatively and remained in the patient's body.The current state of health of the patient is unknown.The device, intended for use in treatment, was returned for investigation.The reported failure mode of "device fracture" can be confirmed.The provided x-rays were reviewed and confirm the reported, broken fin from the trial head that remains in the patient.A review of the batch record revealed no deviations from the standard manufacturing process, that could have contributed to the reported issue.A review of the risk management documentation verifies the failure mode and severity of the reported issue.For the batch in scope no additional complaint was recorded.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all devices must be inspected and controlled for proper functioning after cleaning/disinfection.After the performed investigation we assume that the devices met specification at the time of manufacturing.The reported failure mode of a flap breakage can be confirmed.A relationship between device and reported event can be confirmed.Previous investigations demonstrated that the trial femoral head may disconnect from the stem taper intra-operatively and flaps might break off.These issues are due to high loads, beyond the design limit, that may arise on the tabs during manipulation.The failure modes may further be exacerbated by excessive use of the device over time.This case is nonetheless the only known occurrence of a fragment of the device remaining in the patient out of a total of more than 600¿000 estimated usages.The performance of the device is within the risks level that are anticipated in the risk management documentation, both in occurrence and severity.The current design remains therefore state of the art.As part of the continuous improvement smith + nephew is nonetheless working on a design enhancement, options are currently being reviewed and tested at our facility.The current design will be further monitored through post-market surveillance processes.No further actions are necessary at this time point.

• Brand Name: TRIAL FEMORAL HEAD 32 M/+4
• Common Device Name: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• 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 ; schachenallee 29; aarau CH-50-00 ; SZ CH-5000 ; 5123913905
• MDR Report Key: 11722509
• Report Number: 9613369-2021-00169
• Device Sequence Number: 19587810
• Product Code: LZO
• UDI-Device Identifier: 07611996121841
• UDI-Public: 07611996121841
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K132435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/15/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 75100851
• Device Catalogue Number: 75100859
• Device Lot Number: A62507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 07/07/2021; 08/20/2021; 09/14/2021; 02/07/2022
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 07/08/2021; 08/22/2021; 09/15/2021; 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2017
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Sex: Unknown