MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 52MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number	74122552
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Necrosis (1971); Metal Related Pathology (4530)
Date of Event	03/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H:10 internal reference number: (b)(4).This complaint was opened by smith+nephew to document a patient complication reported that includes reference to the use of a smith+nephew product without evidence about a specific product problem.The reported complication relates to known inherent 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 confirm a relationship between the reported event and the device or 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 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 after undergoing a bhrmh in his right hip joint on (b)(6) 2010, patient experienced failure of right metal-on-metal total hip replacement with metal toxicity.This adverse event was addressed by conducting a revision surgery on (b)(6) 2025, during which, surgeon converted to total hip arthroplasty.While doing the procedure they encountered significant amounts of necrotic appearing synovium which was excised.This was excisional in nature.Also, there was some debris and corrosion on the trunnion.Finally, patient was transferred from the operating room to the recovery room in stable condition.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device finds the device returned with the base behind the cutting block knob damaged, significant material was fractured off and returned alongside the remainder of the device.The entire device is worn from use with degradation of the identification markings.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.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: HEMI HEAD 52MM
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 22326545
• Report Number: 3005975929-2025-00064
• Device Sequence Number: 8289468
• Product Code: KWL
• UDI-Device Identifier: 00885556071694
• UDI-Public: 00885556071694
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2025
• 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): 07/28/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 74122552
• 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: 06/03/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 07/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 112 KG