MAUDE Adverse Event Report: BIOMET ORTHOPEDICS REP II MOD BRNG XL RM/LL 8MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problem No Information (3190)

Event Date 03/04/2016

Event Type  Injury  

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.The following could not be completed with the limited information provided.Expiration date - unknown, date implanted - unknown, manufacture date ¿ unknown.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.".

Event Description

It was reported that the patient underwent an initial partial knee arthroplasty on an unknown date.Subsequently, the patient was revised on (b)(6) 2016 due to poly wear.The bearing was revised.

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 knee revision procedure approximately twenty (20) to twenty-five (25) years post-implantation due to poly wear.During the procedure, the tibial bearing was removed and replaced.

• Brand Name: REP II MOD BRNG XL RM/LL 8MM
• 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: 5514482
• MDR Text Key: 40804940
• Report Number: 0001825034-2016-00944
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK971938
• 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: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 215085
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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