MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 36 L/+8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	75100858
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that one trial femoral head 36 l/+8 is cracked and would not secure to neck trial.As this was noticed upon field inspection, no patient was involved.
Additional Manufacturer Narrative
H3, h6: it was reported that one trial femoral head 32 l/+8 are fractured and won't secure to neck trial.As this was noticed upon field inspection, no patient was involved.The device in scope of this complaint, was returned for investigation.The reported issue could be confirmed upon visual inspection, one of the tabs is completely fractured and a second one is partially fractured.A review of the batch record revealed no deviations from the standard manufacturing process.There are not any indications that the device did not meet the specifications at the time of manufacturing.A review of the complaint history revealed one further complaint for the batch in question with a comparable failure mode.A review of the risk management documentation verifies the failure mode and severity of the reported issue.Based on the performed investigations, the relationship between the reported event and the device was 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.The performance of the device is within the risks level that are anticipated in the risk management documentation.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.Smith & nephew will continue to monitor this device for similar issues.The returned device will be discarded.

• Brand Name: TRIAL FEMORAL HEAD 36 L/+8
• 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: 14739110
• Report Number: 9613369-2022-00312
• Device Sequence Number: 2350603
• Product Code: LZO
• UDI-Device Identifier: 07611996121919
• UDI-Public: 07611996121919
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K132435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 75100858
• Device Catalogue Number: 75100858
• Device Lot Number: A59072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2015
• 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
• Patient Sex: Unknown