MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 52/60; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74122160
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	11/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Event or Problem Description
It was reported that, after a bhr-tha revision surgery had been performed on (b)(6) 2009, the patient experienced a significant acetabular osteolysis and modest femoral osteolysis in likely alval lesion (aseptic lymphocyte-dominant vasculitis associated lesion), without mobilization of the components.This adverse event was addressed by a second revision surgery on (b)(6) 2021 to explant the acetabular cup hap size 52/60 and bhr modular head 52mm.The synergy system was retained and the system was converted to thr with competitor's cup dual mobility liner and ceramic head.It is unknown current health status of patient.
Additional Manufacturer Narrative
It was reported that revision surgery was performed on the patients right hip.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.A review of the historical complaints data for the cup and head was performed.Using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product.No other similar complaints were identified for the cup or head.A search was also performed using part numbers, the reported failure modes and description summary to evaluate patterns of repeated failures or defects in a timeframe of 12 months prior to the date in which the incident was reported.Other similar complaints were identified for the cup.This will continue to be monitored.No other similar complaints have been identified for the head.All the released devices involved met manufacturing specifications at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed for the cup and head.No additional risks were identified as result of the reported event and no further actions are required at this time.The available clinical information was reviewed, based on the reported symptoms it cannot be concluded that the events/clinical reactions (significant acetabular osteolysis and modest femoral osteolysis in likely alval lesion) were associated with a mal-performance of the implant.The patient impact cannot be determined at this time.Without additional information we cannot further investigate or confirm the reported complaint.The 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 the products or additional information become available in the future, this case will be reopened.Based on this investigation, the need for corrective or preventative action is not indicated.

• Brand Name: ACETABULAR CUP HAP SIZE 52/60
• 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: 13280318
• Report Number: 3005975929-2022-00018
• Device Sequence Number: 4964284
• Product Code: NXT
• UDI-Device Identifier: 03596010552327
• UDI-Public: 03596010552327
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2022

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: 09/30/2012
• Device Model Number: 74122160
• Device Catalogue Number: 74122160
• Device Lot Number: 07JW13987
• 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: 12/30/2021
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 03/21/2022
• Date Device Manufactured: 09/30/2007
• 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: Hospitalization; Required Intervention; Other
• Patient Age: 85 YR
• Patient Sex: Unknown