MAUDE Adverse Event Report: BIOMET UK LTD OXFORD ANATOMIC BEARING RT X-SM 4MM PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Torn Material (3024)

Patient Problem Fall (1848)

Event Date 06/21/2012

Event Type  Injury  

Event Description

It was reported that patient underwent initial right partial knee arthroplasty on (b)(6) 2010.Subsequently, patient underwent revision procedures on (b)(6) 2012 and (b)(6) 2015 due to a torn medial collateral ligament.The tibial bearing was removed and replaced during both procedures.Patient underwent a further revision procedure on (b)(6) 2015 due to a dislocated bearing and a torn medial collateral ligament after a patient fall.The tibial bearing was removed and replaced.

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-02714 / 02715).

Manufacturer Narrative

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

• Brand Name: OXFORD ANATOMIC BEARING RT X-SM 4MM PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD; waterlon industrial estate; bridgend, south wales IN 46582 CF3; UK 46582 CF31
• 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: 4880134
• MDR Text Key: 6061207
• Report Number: 0001825034-2015-02714
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2012
• Device Model Number: N/A
• Device Catalogue Number: 160791
• Device Lot Number: 439033
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2007
• 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: 46 YR