MAUDE Adverse Event Report: BIOMET ORTHOPEDICS MAX PRI-LIP TIB BRNG 10X79/83; PROSTHESIS, KNEE

Model Number N/A

Device Problems Delamination (2904); Naturally Worn (2988)

Patient Problem No Information (3190)

Event Date 03/28/2016

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 that this type of event can occur: under possible adverse effects, number 11 states, "wear and/or deformation of articulating surfaces." surgeon didn't approve for return.

Event Description

It was reported that a patient underwent a right total knee arthroplasty on (b)(6) 2000.Subsequently, the patient was revised on (b)(6) 2016 due to poly wear and delamination.The femoral component and bearing were removed and replaced.

• Brand Name: MAX PRI-LIP TIB BRNG 10X79/83
• 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: 5586849
• MDR Text Key: 43013739
• Report Number: 0001825034-2016-01349
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK915132
• 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: 03/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2004
• Device Model Number: N/A
• Device Catalogue Number: 146370
• Device Lot Number: 958320
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/1999
• 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: 70 YR