MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC. PROFEMUR MODULAR NECK; NONE

Device Problem Malfunction (2409)

Patient Problem Surgical procedure, repeated (2042)

Event Date 12/30/2013

Event Type  Injury  

Event Description

A (b)(6) male underwent left hip replacement surgery at another hospital approx ten years ago.The pt underwent revision of left total hip arthroplasty on (b)(6) 2013.Failed implant component: profemur modular neck.Per attending surgeon, the failure appears to be a metal fatigue failure originating in the femur component pocket.Neck was used with lineage ceramic on ceramic acetabular system and profemur z hip stems.

• Brand Name: PROFEMUR MODULAR NECK
• Type of Device: NONE
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC.; arlington TN
• MDR Report Key: 3581683
• MDR Text Key: 4061684
• Report Number: 3581683
• Device Sequence Number: 1
• Product Code: LZO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/02/2014
• Distributor Facility Aware Date: 01/02/2014
• Event Location: Hospital
• Date Report to Manufacturer: 01/02/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 53 YR