MAUDE Adverse Event Report: SMITH AND NEPHEW BIRMINGHAM RESURFACING

Catalog Number 74123152

Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)

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

Event Date 12/04/2013

Event Type  Injury  

Event Description

Had a smith and nephew birmingham resurfacing device implanted in december 2013.Started having problem is constant pain, squeaky noise, high levels of cobalt and chromium in my blood, pocket of metal in my hip joint (b)(6) 2016 had to have revision surgery.Still having pain from the account they had to remove from my damaged hip.

• Brand Name: BIRMINGHAM RESURFACING
• Type of Device: BIRMINGHAM RESURFACING
• Manufacturer (Section D): SMITH AND NEPHEW
• MDR Report Key: 6173636
• MDR Text Key: 62462592
• Report Number: MW5066687
• Device Sequence Number: 1
• Product Code: NXT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/01/2016
• Device Catalogue Number: 74123152
• Device Lot Number: 11KW34534
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: PROTONICS
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 51 YR
• Patient Weight: 93