MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VGXP XP E1 TIBIAL BEARING RL 10X63; PROSTHESIS, KNEE

Model Number N/A

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem No Code Available (3191)

Event Date 08/04/2015

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.This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2015-03674 / 03675).

Event Description

It was reported that patient underwent a right total knee arthroplasty on (b)(6) 2015.Subsequently, patient was revised on (b)(6) 2015 due to tightness and stiffness.The tibial tray and tibial bearings were removed and replaced.

• Brand Name: VGXP XP E1 TIBIAL BEARING RL 10X63
• 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: 5013523
• MDR Text Key: 23421917
• Report Number: 0001825034-2015-03675
• 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: company representative
• Reporter Occupation: Physician
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/25/2019
• Device Model Number: N/A
• Device Catalogue Number: 195773
• Device Lot Number: 529540
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2014
• 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: 73 YR