MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 50MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74120150
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); High metal ion levels (4847)
Date of Event	12/19/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient who received a right birmingham hip resurfacing (bhr) system on (b)(6) 2007, experienced implant-related complications associated with elevated metal ion levels.Laboratory tests showed increased concentrations of chromium and cobalt, indicative of potential adverse local tissue reaction (altr).A revision procedure was reportedly performed on (b)(6) 2017, to address the condition.The current health status of the patient is unknown.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H6: this complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate 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 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.
Additional Manufacturer Narrative
H9: the modular head listed as concomitant product in d10 was subject to the following action reported to fda under 21 usc 360i(f): z-0584-20136.H3, h6: as of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.A review of the historical complaints data for the alleged devices was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified for the cup and the syn por fem comp; no other similar complaints have been identified for the modular head.This failure will continue to be monitored via routine trending.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.The review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions are required.The available medical documents were reviewed.The cobalt 67.1 and chromium 54.2 mcg/l are consistent with the reported cobalt toxicity.However, the clinical root cause for the elevated cobalt and chromium cannot be confirmed.The patient¿s extensive medical and surgical history cannot be ruled out as a likely contributing factor to the noted global muscle weakness.Bhr implants were implanted bilaterally (2006, 2007) and revised (b)(6) 2017 as indicated in a clinic note.However, a definitive course of events cannot be confirmed as the patient had multiple revisions noted and operative reports were not provided.(b)(6) 2013 pending right hip prosthesis replacement: events related to this cannot be confirmed.(b)(6) 2018 clinic note indicated cobalt toxicity after revision total hip arthroplasty following ceramic-head fracture 2017; however, it is also noted patient had bhr (cobalt/chrome) implants in 2017.Events related to the ceramic-head fracture cannot be confirmed.(b)(6) 2021 metallosis.Right cup revision: post bhr revision.The patient impact is determined to be elevated metal ions and bilateral bhr revisions.A definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement, loosening of components may increase production of wear particles and accelerate damage to the bone.Should the devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: ACETLR CUP HAP 50MM W/ IMPTR
• 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: 22462556
• Report Number: 3005975929-2025-00071
• Device Sequence Number: 12906320
• Product Code: NXT
• UDI-Device Identifier: 03596010502568
• UDI-Public: 03596010502568
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2010
• Device Catalogue Number: 74120150
• Device Lot Number: 52802
• 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: 06/09/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2005
• 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: PART# 74121442, LOT#: 64754.; PART#: 71306613, LOT#: 06JM00328.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male