MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BIRMINGHAM HIP RESURFACING; RESURFACING FEMORAL HEAD 50MM

Catalog Number 74121150

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problems Toxicity (2333); Injury (2348)

Event Date 06/05/2018

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to metallosis and elevated levels of cobalt and chromium.

Event Description

Revision surgery findings stated the femoral component was grossly loose.The acetabular component was well positioned and solidly fixed, it was retained.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to metallosis and elevated levels of cobalt and chromium.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 revision operative report indicated failure of the total hip arthroplasty as the indication for revision, but did not specifically note metallosis nor elevated cobalt and chromium levels.During revision, the femoral component was noted to be grossly loose.Although it was reported that the cobalt and chromium levels were elevated, no levels were provided.The intraoperative finding of loosening of the femoral component can be seen as a result of metallosis but also changes in position or loosening could also accelerate wear and led to metal debris and result in metallosis; however, without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported metallosis, elevated cobalt and chromium levels, and loosening of the femoral component cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a malperformance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, however based on the received information a potential root cause for this is loosening.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: BIRMINGHAM HIP RESURFACING
• Type of Device: RESURFACING FEMORAL HEAD 50MM
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 7863336
• MDR Text Key: 119780684
• Report Number: 3005975929-2018-00305
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502797
• UDI-Public: 03596010502797
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2010
• Device Catalogue Number: 74121150
• Device Lot Number: 059370
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETBAULAR CUP, # 74120150, LOT # UNKNOWN; ACETBAULAR CUP, # 74120150, LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention