MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 44/50; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74122150
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Metal Related Pathology (4530)
Date of Event	09/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after the plaintiff underwent a left bhr-tha surgery on (b)(6) 2010 due to bilateral osteoarthritis, she experienced pain and this was interfering with her daily activities.A decreased range of motion was noticed as well.It was determined that the metal-on-metal articulation with asr cup implanted had failed.This adverse event was addressed by performing a revision surgery on (b)(6) 2025, during which surgeon converted to total hip replacement arthroplasty.There were metal debris present on the inside of the femoral head and the trunnion.There was approximately 30% abductor damage as a direct result of metallosis damage to the abductor muscles.The stem was stable and well fixed, so it was not revised.The surgeon noticed metallosis stained tissue throughout the hip joint, most pronounced anterior hip capsule and surrounding the proximal femoral stem.It was also extensive along the posterior capsule and soft tissues of proximal femur; and along the backside of the acetabular implant.The cup was easily removed, the head was noticed to have metal debris inside the trunnion area, this was removed and replaced.The stem trunnion also had metal debris but was still in good shape overall.Stability was an issue initially due to the abductor damage and impingement anterior from extensive scar tissue, so the surgeon decided to lengthen the patient's leg a little longer than the contralateral to give her a stable hip joint.Patient reversed from anesthesia and sent to pacu in stable condition.
Additional Manufacturer Narrative
Internal complaint 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.

• Brand Name: ACETABULAR CUP HAP SIZE 44/50
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• 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: 25439193
• Report Number: 3005975929-2026-00020
• Device Sequence Number: 6038959
• Product Code: NXT
• UDI-Device Identifier: 03596010552273
• UDI-Public: 03596010552273
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• 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: Other,Consumer,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/30/2014
• Device Catalogue Number: 74122150
• Device Lot Number: 09MW25222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Supplement Date Received by Manufacturer: 06/25/2026
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 07/27/2026
• Date Device Manufactured: 12/31/2009
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3L92512/50226519 (DEPUY FRANCE CORAIL); 74222144/10AW25584
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 145 LB