MAUDE Adverse Event Report: BIOMET UK LTD OXFORD ANATOMIC BEARING RT MD SIZE 5 PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 10/03/2014

Event Type  Injury  

Event Description

It was reported that the patient underwent a right partial knee arthroplasty on (b)(6), 2014.Subsequently, a revision procedure was performed on (b)(6) 2014 due to an unknown reason.The tibial bearing was removed and replaced.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly related to the event.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information and additional information, which was unknown at the time of the initial medwatch.Product location unknown.

• Brand Name: OXFORD ANATOMIC BEARING RT MD SIZE 5 PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD; waterton industrial estate; bridgend IN CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4237353
• MDR Text Key: 17575984
• Report Number: 0001825034-2014-08552
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 159577
• Device Lot Number: 2695413
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR