MAUDE Adverse Event Report: BIOMET, INC. OXFORD UNICOMPARTMENTAL TIBIAL TRAY; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYM

Catalog Number 154718

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/19/2016

Event Type  Injury  

Event Description

Left knee uni-compartmental implants failed.Implants explanted and replaced with a complete knee replacement.

• Brand Name: OXFORD UNICOMPARTMENTAL TIBIAL TRAY
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYM
• Manufacturer (Section D): BIOMET, INC.; 56 east bell drive p.o.box 587; warsaw IN 46581
• MDR Report Key: 5500221
• MDR Text Key: 40323970
• Report Number: 5500221
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 154718
• Other Device ID Number: TWIN PEG FEMORAL MD PMA 16146
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/14/2016
• Device Age: 1 YR
• Date Report to Manufacturer: 03/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 91