MAUDE Adverse Event Report: BIOMET UK LTD OXF ANAT BRG RT LG SIZE 4 PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Swelling (2091)

Event Date 05/13/2015

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.(b)(4).This report is based on allegations set forth in patient¿s complaint, and the allegations contained therein are unverified.

Event Description

It was reported that patient underwent right partial knee arthroplasty on (b)(6) 2010.Subsequently, patient underwent revision procedure on (b)(6) 2015 due to pain and swelling.Competitor products were used to complete the procedure.Patient further alleged a defect in the metal coating on one component.This report is based on allegations set forth in patient's complaint, and the allegations contained therein are unverified.

Manufacturer Narrative

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

• Brand Name: OXF ANAT BRG RT LG SIZE 4 PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD; waterton industrial estate; brigend 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: 5163427
• MDR Text Key: 28808674
• Report Number: 0001825034-2015-04386
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Followup
• Report Date: 10/21/2015

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: 12/31/2013
• Device Model Number: N/A
• Device Catalogue Number: 159583
• Device Lot Number: 622920
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2008
• 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 Weight: 76