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

Catalog Number 74120154

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Osteolysis (2377); Test Result (2695)

Event Date 06/12/2019

Event Type  Injury  

Event Description

It was reported a left hip revision surgery was performed due mom metallosis, significant osteolysis, groin pain, elevated test results.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision all devices were removed.As of today, device return and additional information has been requested for this complaint but has not become available.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.The available medical documents were reviewed.The reported pain caused by degenerative changes, increased co and cr ion levels and osteolysis noted in the acetabular cup with a necrotic type metal debris around the pseudocapsule were consistent of findings associated with metallosis.The patient had a history of a fall after her initial index surgery.However, without the supporting lab results, imaging and the analysis of the explanted components the source of reactions cannot be confirmed.Further, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: ACETLR CUP HAP 54MM W/ IMPTR
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 9183982
• MDR Text Key: 162362979
• Report Number: 3005975929-2019-00364
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502582
• UDI-Public: 03596010502582
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/29/2013
• Device Catalogue Number: 74120154
• Device Lot Number: 090313
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANTHOLOGY HO POROUS SZ 5 71356105/ 08BM09386; HEMI HEAD 46MM 74122546/ 08JW18838; MODULAR SLEEVE PLUS 0MM 12/14 74222200/ 08JM19032
• Patient Outcome(s): Other
• Patient Age: 68 YR