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

Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problem Test Result (2695)

Event Date 01/24/2011

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to metallosis and incompatibility metal wear.Acetabular cup reportedly implanted on (b)(6) 2003.Bhr modular head and zimmer cls stem implanted on (b)(6) 2003.

• Brand Name: BHR
• Type of Device: ACETABULAR CUP
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; 1 kingmaker court; warwick technology park; warwick CV34 6WG; UK CV34 6WG
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; 1 kingmaker court; warwick technology park; warwick CV34 6WG; UK CV34 6WG
• Manufacturer Contact: jennifer ferguson ; 4419264823
• MDR Report Key: 3752222
• MDR Text Key: 4483262
• Report Number: 3005477969-2014-00242
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ZIMMER FEMORAL STEM, PART 29.00.09-112, LOT2157793; MODULAR HEAD, PART #74121454 AND LOT #30207
• Patient Outcome(s): Hospitalization; Required Intervention