MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 36 XS/-3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	75100855
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that, during a tha, one (1) trial femoral head 36 xs/-3 got stuck in the acetabular portion.The surgeon tried to use a hook to dislocate the hip and remove the trial without success, so an osteotome was used.The osteotome slide and broke the trial head inside the wound.All pieces were removed with clamp and the wound was washed with pulsejet the procedure was resumed, without any delay, using an equivalent s+n back-up.No further complications were reported.
Additional Manufacturer Narrative
The complaint device used in treatment has not been completely returned.A visual evaluation of the returned part was conducted, and it was concluded that the device returned fractured into several pieces with significant material not returned, the edges scraped and gouged and the surfaces damaged.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 only 1 additional similar complaint reported for the same batch, and 8 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.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.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.The root cause of the event can be attributed to a known inherent risk of the device.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint.However, smith & nephew will continue to monitor for future complaints and investigate as necessary.This complaint investigation is considered closed.The returned device will be discarded.
Additional Manufacturer Narrative
Internal reference number: case-(b)(4).G4 has been corrected.

• Brand Name: TRIAL FEMORAL HEAD 36 XS/-3
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau TN CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau TN CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 25325415
• Report Number: 9613369-2026-00039
• Device Sequence Number: 21316823
• Product Code: LZO
• UDI-Device Identifier: 07611996121889
• UDI-Public: 7611996121889
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/05/2026

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: 75100855
• Device Lot Number: A75299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Supplement Date Received by Manufacturer: 07/11/2026; 06/11/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 07/05/2026; 07/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown