MAUDE Adverse Event Report: BIOMET ORTHOPEDICS OXF TWIN-PEG CMNTD FEMORAL LG PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 07/10/2015

Event Type  Injury  

Event Description

It was reported that patient underwent a right partial knee arthroplasty in (b)(6) 2014.Subsequently, patient was revised on (b)(6) 2015 due to femoral loosening.The tibial bearing was removed and replaced and the femoral component was re-cemented.

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.

Manufacturer Narrative

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

Event Description

It was reported that patient underwent a right partial knee arthroplasty in (b)(6) 2014.Subsequently, patient was revised on (b)(6) 2015 due to femoral loosening.The tibial bearing was removed and replaced and the femoral component was re-cemented.

• Brand Name: OXF TWIN-PEG CMNTD FEMORAL LG PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• 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: 4965030
• MDR Text Key: 6640435
• Report Number: 0001825034-2015-03536
• 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
• Report Date: 08/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 161470
• Device Lot Number: 703240
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2014
• 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