MAUDE Adverse Event Report: BIOMET INC OXFORD PARTIAL KNEE BEARING TIBIAL MEDIUM ANATOMIC RIGHT MEN; PROSTHETIC KNEE

Catalog Number 159578

Device Problem Unstable (1667)

Patient Problem No Code Available (3191)

Event Date 06/01/2015

Event Type  malfunction  

Event Description

Approximately 1.5 years after initial surgery, patient developed unstable meniscal bearing.The patient underwent revision unicompartmental arthroplasty(meniscal bearing exchange, 6 mm for 9 mm thick component).
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manufacturer response for bearing tibial medium anatomic right meniscal unicondular oxford, bearing tibial medium anatomic right meniscal unicondular oxford (per site reporter).
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vendor and md were handling as a warranty matter with patient.

• Brand Name: OXFORD PARTIAL KNEE BEARING TIBIAL MEDIUM ANATOMIC RIGHT MEN
• Type of Device: PROSTHETIC KNEE
• Manufacturer (Section D): BIOMET INC; 56 east belt drive; p.o. box 587; warshaw IN 46581
• MDR Report Key: 4867728
• MDR Text Key: 6262359
• Report Number: 4867728
• Device Sequence Number: 1
• Product Code: NRA
• 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: 06/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 159578
• Device Lot Number: 2762649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2015
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/15/2015
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/15/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 118