MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 36 S/+0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	75100856
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, during a thr surgery, one of the tabs inside one (1) trial femoral head 36 s/+0 broke off.All pieces were accounted for.It is unknown how the procedure was completed, however, no injury or any delay were reported as a consequence of this issue.
Additional Manufacturer Narrative
Investigation was finished.Sections h6 (type of investigation, investigation findings and conclusions) and h11 were updated.Internal complaint reference: case-(b)(4).H11: the product was not returned for evaluation, however, previous complaints were received and investigated for this part number, in which the reported failure mode was confirmed.No batch number was communicated so the production history review was not possible.Due to an unknown batch number, the review of historical complaints was performed on product number basis only, revealing 15 additional complaints over the past 12 months with similar failure mode.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.The root cause of the event can be attributed to a known inherent risk of the device.Previous investigations demonstrated that the trial femoral head may disconnect from the stem taper intra-operatively and flaps might bend or break off.These failure modes may further be exacerbated by excessive use of the device over time.The performance of the device is still within the risks level that are anticipated in the risk management documentation.The current design will be further monitored through post-market surveillance processes.No further actions are necessary at this time point.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
Additional Manufacturer Narrative
Additional information: d4 (lot number and expiration date), d9, h4.
Additional Manufacturer Narrative
The complaint device intended for use in treatment not been completely returned.A visual evaluation of the device was conducted, and it was concluded that one of the inner flaps fractured off and is missing.There is also a crack in another flap.Furthermore, there are signs of wear such as scratches and dents.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.The review of historical complaints for the alleged device revealed no additional similar complaints reported for the same batch, and 15 additional similar complaints for the same product number over the past 12 months with similar a failure mode.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.The root cause of the event can be attributed to a known inherent risk of the device.Previous investigations demonstrated that the trial femoral head may disconnect from the stem taper intra-operatively and flaps might bend or break off.These failure modes may further be exacerbated by excessive use of the device over time.The performance of the device is still within the risks level that are anticipated in the risk management documentation.The current design will be further monitored through post-market surveillance processes.No further actions are necessary at this time point.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.The returned device will be discarded.

• Brand Name: TRIAL FEMORAL HEAD 36 S/+0
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 22392126
• Report Number: 9613369-2025-00107
• Device Sequence Number: 9160252
• Product Code: LZO
• UDI-Device Identifier: 07611996121896
• UDI-Public: 7611996121896
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/21/2025

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 Catalogue Number: 75100856
• Device Lot Number: A74122
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 07/22/2025; 08/26/2025; 10/15/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 07/29/2025; 08/29/2025; 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2021
• 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
• Patient Sex: Unknown