MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 58MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74120158
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Unspecified Infection (1930); Metal Related Pathology (4530)
Date of Event	10/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
*us legal* it was reported that the plaintiff suffered from a purulent infection of the left hip and needed an irrigation and debridement procedure on (b)(6) 2022.During this procedure, a significant amount of grey necrotic appearing tissue was observed, which is indicative for metallosis.Unfortunately, the patient continued to be febrile and began having cellulitis around the incision and a ct guided aspiration confirmed recurrent infection.A 2-step revision surgery had to be performed on (b)(6) 2020 (first step) and on (b)(6) 2021 (second step).The primary bhr left hip surgery was performed on (b)(6) 2009.
Event or Problem Description
It was reported that the plaintiff suffered from a purulent infection of the left hip and needed an irrigation and debridement procedure on (b)(6) 2020.During this procedure, a significant amount of grey necrotic appearing tissue was observed, which is indicative for metallosis.Unfortunately, the patient continued to be febrile and began having cellulitis around the incision and a ct guided aspiration confirmed recurrent infection.A 2-step revision surgery had to be performed on (b)(6) 2020 (first step) and on (b)(6) 2021 (second step).The primary bhr left hip surgery was performed on (b)(6) 2009.
Additional Manufacturer Narrative
H3, h6.It was reported that the patient suffered from a purulent infection of the left hip and needed an irrigation and debridement procedure.During this procedure a significant amount of grey necrotic appearing tissue was observed, which is indicative for metallosis.The patient continued to be febrile and began having cellulitis around the incision and a ct guided aspiration confirmed recurrent infection.A two step revision surgery was performed on (b)(6) 2020 and (b)(6) 2021.A review of the historical complaints data for the devices was performed using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint aware date.No other similar complaints were identified to involve the batches concerned.Other similar complaints were identified for the part numbers and the reported failure mode.This will continue to be monitored.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.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.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.With the information provided the clinical root cause of the infection and subsequent irrigation and debridement, and 2-stage revision cannot be confirmed.However, the infection is highly likely of an exogenous nature and there is no evidence that our product contributed to the infection.With the limited information provided, the clinical root cause of the reported metallosis cannot be confirmed.The patient impact beyond the infection, irrigation and debridement, revision and expected transient post-op convalescence period cannot be determined.Based on the available information we can confirm the reported complaint, however without further information our investigation remains inconclusive, and a definitive root cause cannot be determined.Additionally, specific factors known to contribute to the alleged fault cannot be provided due to the insufficient information.If additional information becomes available in the future, this case will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.¿ ¿ ¿.

• Brand Name: ACETLR CUP HAP 58MM 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14429410
• Report Number: 3005975929-2022-00249
• Device Sequence Number: 20209179
• Product Code: NXT
• UDI-Device Identifier: 03596010502605
• UDI-Public: 03596010502605
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/10/2022

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: 06/22/2013
• Device Model Number: 74120158
• Device Catalogue Number: 74120158
• Device Lot Number: 089866
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 06/09/2022; 08/10/2022
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 06/09/2022; 08/10/2022
• Date Device Manufactured: 06/23/2008
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male