MAUDE Adverse Event Report: BIOMET, INC.; PROSTHESIS, HIP, HEAD

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Date 06/17/2014

Event Type  malfunction  

Event Description

Failed left total hip arthroplasty with metal reaction.Revision left total hip arthroplasty, acetabular component and femoral head.

• Type of Device: PROSTHESIS, HIP, HEAD
• Manufacturer (Section D): BIOMET, INC.; 56 east bell dr.; po box 587; warsaw IN 46581
• MDR Report Key: 4239350
• MDR Text Key: 5018183
• Report Number: 4239350
• Device Sequence Number: 1
• Product Code: KWY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 10/03/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/06/2014
• Device Age: 9 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/10/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2014
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 95