MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VGXP POROUS FEMORAL LT 67.5; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/29/2015

Event Type  malfunction  

Manufacturer Narrative

Health hazard evaluation found implant to be out of design specifications and confirmed product non-conformance.Corrective and preventative action has been initiated.

Event Description

It was reported that patient underwent an initial total knee arthroplasty on (b)(6) 2015.During the procedure, that the surgeon had concerns about the geometry not matching the 4 in 1 cuts that were made.He felt the implant went on with less resistance than a regular porous vanguard femoral.There was no delay in procedure and no injury to patient.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Results - inadequate quality inspection method.Product location unknown.

• Brand Name: VGXP POROUS FEMORAL LT 67.5
• 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: 5303807
• MDR Text Key: 34330261
• Report Number: 0001825034-2015-02599
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK141407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 195947
• Device Lot Number: 961890
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2015
• Initial Date FDA Received: 12/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/17/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/02/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2015-017R
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 110