MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VNGD XP INLK PRI TIB TRAY 67MM; PROSTHESIS, KNEE

Model Number N/A

Device Problems Device Slipped (1584); Unstable (1667)

Patient Problem Pain (1994)

Event Date 12/05/2014

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 4 states, "loosening, migration, or fracture of the implants can occur due to loss of fixation, trauma, malalignment, malposition, non-union, bone resorption and/or excessive unusual and/or awkward movement and/or activity and/or excessive weight." number 6 states, "inadequate range of motion due to improper selection or positioning of components." number 14 states, "patellar tendon rupture and ligamentous laxity." number 15 states, "interoperative or postoperative bone fracture and/or postoperative pain.".

Event Description

It was reported that the clinical patient underwent an initial right total knee arthroplasty on (b)(6) 2013.Subsequently, the patient was revised on (b)(6) 2014 due to pain, attrition of the anterior cruciate ligament, mild mediolateral instability, and early aseptic loosening.The bearing, tibial tray, and locking bar were removed and replaced.Operative report noted clear fluid during the procedure.

Manufacturer Narrative

This follow-up report is being filed to relay this report is a duplicate of 1825034-2015-00826.

• Brand Name: VNGD XP INLK PRI TIB TRAY 67MM
• 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: 5305439
• MDR Text Key: 33710983
• Report Number: 0001825034-2015-05034
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK122160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 195247
• Device Lot Number: 372960
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2015
• Initial Date FDA Received: 12/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2013
• 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: 74 YR
• Patient Weight: 83