MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VGXP XP MED TIBIAL BEARING RT 10X71; PROSTHESIS, KNEE

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Osteolysis (2377)

Event Date 12/02/2015

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 or deviation.There are warnings in the package insert that state this type of event can occur: under possible adverse effects, number 1 states, "it has been reported that wear debris may initiate a cellular response resulting in osteolysis, or osteolysis may be a result of loosening of the implant.".

Event Description

It was reported that patient underwent right total knee arthroplasty on (b)(6) 2015.Subsequently, a revision procedure was performed on (b)(6) 2015 due to tibial osteolysis.A review of invoice history reveals the polyethylene tibial bearing and locking bar were removed and replaced during the procedure.

• Brand Name: VGXP XP MED TIBIAL BEARING RT 10X71
• 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: 5433877
• MDR Text Key: 38119631
• Report Number: 0001825034-2016-00465
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK132873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/17/2019
• Device Model Number: N/A
• Device Catalogue Number: 195850
• Device Lot Number: 158250
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2014
• 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
• Patient Age: 56 YR