MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 32 XS/-3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	75100849
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H3, h6: 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 investigative findings or 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 thr surgery, one (1) trial femoral head 32 xs/-3 was broken.It is unknown how procedure was completed or if there was surgical delay.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
Investigation was finished.Sections h.6.(type of investigation, investigation findings and conclusions) and h.11.Were updated.Internal complaint reference: (b)(4).H.11.: 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.Furthermore, a visual inspection of a picture sent by the complainant confirms the device is damaged.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 1 additional complaint 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.

• Brand Name: TRIAL FEMORAL HEAD 32 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 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: 22488787
• Report Number: 9613369-2025-00111
• Device Sequence Number: 15464125
• Product Code: LZO
• UDI-Device Identifier: 07611996121827
• UDI-Public: 7611996121827
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2025

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: 75100849
• Device Lot Number: UNKNOWN
• 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: 06/19/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 07/12/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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