MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 52MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74120152
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Osteolysis (2377); Joint Laxity (4526); Medical device site infection (4845); High metal ion levels (4847)
Date of Event	10/31/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision surgery on (b)(6) 2016 due to implant loosening and elevated metal ion levels (cr 40.9 g/l, co 69.2 g/l).Pre-revision evaluation also identified osteolysis and prior infection.The acetabular shell was replaced using an r3 system with ceramic-on-ceramic components.No operative report was provided.The revision was completed without reported delay or surgical complications.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3,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 device listed as concomitant was subject to an action reported to fda.21 usc 360 reference: (b)(4).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.No similar complaints have been identified for the syn ha ho and the 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.There is a likely route cause to the reported events.The patient¿s clinical history of superinfection cannot be ruled out as a likely contributing factor to the loosening, elevated metal ions and osteolysis.The superinfection and can lead to implant loosening, accelerated wear of the implants, and subsequently elevated metal ions and osteolysis.A definitive root cause cannot be determined.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 52MM 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: 22492960
• Report Number: 3005975929-2025-00076
• Device Sequence Number: 19863825
• Product Code: NXT
• UDI-Device Identifier: 03596010502575
• UDI-Public: 03596010502575
• 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: 2009
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2025

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: 03/30/2013
• Device Catalogue Number: 74120152
• Device Lot Number: 08CW16245
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2008
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2746-2015
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PART#: 71306413, LOT#: 06DM13686A; PART#:74121546, LOT#: 50191
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female