MAUDE Adverse Event Report: BIOMET ORTHOPEDICS OXF ANAT BEARING LT MD SIZE 3 PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problem Failure of Implant (1924)

Event Date 06/11/2015

Event Type  Injury  

Event Description

It was reported that patient underwent a left partial knee arthroplasty on (b)(6) 2011.Subsequently, patient was revised on (b)(6) 2015 due to instability and pitting in the bearing.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 or deviation.There are warnings in the package insert that state that this type of event can occur: under precautions, number 4 states, "excessive, unusual and/or awkward movement and/or activity, trauma, excessive weight, and obesity have been implicated with premature failure of the implant by loosening, fracture, dislocation, subluxation and/or wear." under possible adverse effects, number 16 states, "wear and/or deformation of articulating surfaces.".

Manufacturer Narrative

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

Manufacturer Narrative

This follow-up report is being filed to correct information.

• Brand Name: OXF ANAT BEARING LT MD SIZE 3 PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET ORTHOPEDICS; waterton industrial estate; bridgend
• Manufacturer (Section G): BIOMET ORTHOPEDICS; waterton industrial estate; bridgend
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4931914
• MDR Text Key: 6014817
• Report Number: 0001825034-2015-03197
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 159547
• Device Lot Number: 2475793
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/02/2015
• Initial Date FDA Received: 07/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2011
• 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