MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VGXP XP E1 TIB BRG RM 11X63; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Damage to Ligament(s) (1952)

Event Date 01/26/2015

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 sections could not be completed with the limited information provided.Initial reporter - dr.(b)(6).Event is being reported to fda on one medwatch as the limited information available indicates that a revision procedure occurred.Should additional information be received regarding the revision procedure, the complaint will be reassessed and further medwatch reports will be submitted, if necessary.Product location unknown.

Event Description

Patient underwent a knee revision procedure due to acl impingement.No further information has been provided.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.This report is number 1 of 2 mdr's filed for the same patient (reference 1825034-2016-01898 / 03125).

Event Description

It was reported that patient underwent a right knee revision procedure approximately 11 months post-implantation due to acl impingement.During the procedure, the tibial tray and bearing were removed and replaced.

• Brand Name: VGXP XP E1 TIB BRG RM 11X63
• 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: 5694279
• MDR Text Key: 46373974
• Report Number: 0001825034-2016-01898
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/18/2019
• Device Model Number: N/A
• Device Catalogue Number: 195844
• Device Lot Number: 126770
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2014
• 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: 62 YR
• Patient Weight: 63