MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD UNKNOWN BIRMINGHAM HIP RESURFACING (BHR) CUP (UNKN TYPE); KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER

Catalog Number 74120156

Device Problems Compatibility Problem (2960); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Injury (2348); Ambulation Difficulties (2544)

Event Date 11/16/2017

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed on the patients left hip due to pain, limited mobility, elevated metal ion levels, sciatic nerve damage, and infection which was likely linked to alval.

Manufacturer Narrative

H3, h6: it was reported that hip revision surgery was performed.During the revision the bhr head and bhr cup 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 bhr cup and head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified.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.Sterilization was confirmed through review of the sterilization certificates.Review of the product's instructions for use found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as a result of the reported event.The available medical documents were reviewed.The clinical information provided, of the ¿mildly¿ elevated metal ion levels and the chronic staphylococcus epidermidis and the ¿white chalky material¿ are not the usual presentation, seen in a reaction to metal debris but it cannot be entirely ruled out.The surgeon also stated in the first stage of the revision; ¿there was no obvious wear of either the femoral prosthesis or the acetabular prosthesis.¿ the source and the root cause of these symptoms cannot be determined with the available documentation.It cannot be concluded that the reported clinical findings are associated with the implant failure 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 preventive or corrective action has been initiated as a result of this investigation.

• Brand Name: UNKNOWN BIRMINGHAM HIP RESURFACING (BHR) CUP (UNKN TYPE)
• Type of Device: KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 10260942
• MDR Text Key: 198481670
• Report Number: 3005975929-2020-00235
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 74120156
• Device Lot Number: 16CW01823
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention