MAUDE Adverse Event Report: BIOMET UK LTD OXF ANAT BRG RT SM SIZE 3 PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Human-Device Interface Problem (2949)

Patient Problem No Code Available (3191)

Event Date 09/15/2014

Event Type  Injury  

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.

Event Description

It was reported that the patient underwent an initial partial knee arthroplasty on (b)(6) 2013.Subsequently, patient was revised on (b)(6) 2014 due to patient being dissatisfied with initial implants.All components were removed and replaced.

Manufacturer Narrative

The returned bearing was evaluated and was found to have been manufactured within specifications.Visual examination of the bearing showed very little/normal wear for a bearing that had been recently implanted in a patient.

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.

• Brand Name: OXF ANAT BRG RT SM SIZE 3 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: 4153384
• MDR Text Key: 16588459
• Report Number: 0001825034-2014-08018
• 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,Followup
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 159568
• Device Lot Number: 2742143
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2012
• 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