MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP 54MM WITH IMPACTOR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74120154
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); Medical device site infection (4845); High metal ion levels (4847)
Date of Event	01/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a reported patient complication that includes reference to the use of a smith+nephew product without evidence of 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 conservatively submitting this report in accordance with applicable regulations.If additional 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 the patient underwent a left metal-on-metal bhr tha on (b)(6) 2009, woke up on (b)(6) 2023 with fever, left sided non-traumatic hip pain and was unable to move, walk or bear weight.An aspiration was performed on (b)(6) 2023 which confirm a staph lugdunensis.A revision surgery was performed on (b)(6) 2023 due to infection.Significant pus was found throughout the hip joint and into the iliac fossa, tracking distally to below the lesser trochanter.The hip was washed out and previous acetlr cup hap 54mm w/ imptr and resurfacing femoral head 46mm were explanted.Competitor implants (zimmer) were implanted in order to replace the removed implant.The current health status of the patient is unknown.
Additional Manufacturer Narrative
Correction: h6 (health effect - clinical code, investigation findings and investigation conclusions).Additional information: h6 (type of investigation), h7, h11 (roi).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.No other similar complaints have been identified for the cup 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.Infection is a known risk of joint replacement surgery.The bhr ifu (part no.81040829 rev.0 12/05) warns, ¿superficial or deep infection.Infections may occur months to years after surgery and these infections are difficult to treat and may require reoperation with removal surgery and later replacement at another time.¿ the infection was 13.5-years post implantation and is highly likely of an exogenous nature.It cannot be concluded the osteolysis, elevated metal ions, and infection were associated with a mal performance of the implant.The root cause can be traced to environment.Specific factors known to contribute to the alleged fault are damage to the package during transport or handling, prolonged surgical time, contaminated surgical environment and/or instruments, insufficient care of the surgical wound, incorrect and/or insufficient use of prophylactic antibiotics, excessive patient weight, patient smoking, patient compromised immune system.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: ACETABULAR CUP HAP 54MM WITH IMPACTOR
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 21580171
• Report Number: 3005975929-2025-00010
• Device Sequence Number: 8757103
• Product Code: NXT
• UDI-Device Identifier: 03596010502582
• UDI-Public: 03596010502582
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2013
• Device Catalogue Number: 74120154
• Device Lot Number: 090057
• 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: 02/12/2025
• Supplement Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2008
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RESURFACING FEMORAL HEAD 46MM: 74121146, 087972
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 63 KG