MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BIRMINGHAM HIP RESURFACING; BHR ACETABULAR CUP

Catalog Number 74120148

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Swelling (2091); Tissue Damage (2104); Toxicity (2333); Test Result (2695)

Event Date 07/18/2018

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to pseudotumour, metallosis, elevated metal ion levels, and tissue changes consistent with metal on metal wear.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the acetabularcup & femoral head were removed.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 complaint history for the cup + head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the cup + head.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Device history record review confirmed that all released parts met specifications applicable 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.No additional risks were identified as result of the reported event.The medical documents were reviewed.Although the cobalt and chromium levels were reported to be elevated, neither the levels nor the lab reports were provided.The reported intraoperative findings of a pseudotumor, purulent fluid, and necrotic debris are consistent with findings associated with metallosis; however, without the supporting lab results, imaging, and the analysis of the explanted components, the root cause of the reported elevated metal ions, pseudotumor, metallosis, purulent fluid, and ¿necrotic debris associated with metallosis¿ cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with a mal-performance 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, 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: BIRMINGHAM HIP RESURFACING
• Type of Device: BHR ACETABULAR CUP
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 8036796
• MDR Text Key: 126065341
• Report Number: 3005975929-2018-00417
• Device Sequence Number: 1
• Product Code: NXT
• 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: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: 74120148
• Device Lot Number: 11CW31996
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD, PART AND LOT # UNKNOWN.; HEAD 74121142, LOT 097863A.; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention