MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VGXP XP E1 TIB BRG RM 9X71; PROSTHESIS, KNEE

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Insufficient Information (3190)

Patient Problems Abscess (1690); Pain (1994); Loss of Range of Motion (2032); Weakness (2145)

Event Date 09/21/2015

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.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 6 states, ¿inadequate range of motion due to improper selection or positioning of components.¿ number 14 states, "postoperative bone fracture and pain." this report is number 2 of 2 mdr's filed for the same event (reference 1825034-2014-06097-1 / 2016-00285).

Event Description

It was reported a patient enrolled in a clinical study underwent a right total knee arthroplasty on (b)(6) 2013.It was further reported patient developed a suture abscess on (b)(6) 2014; however, no revision procedure has been reported.Subsequently, patient was revised on (b)(6) 2015 due to limited range of motion, pain and weakness.

Manufacturer Narrative

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

Manufacturer Narrative

This follow up report is being filed to relay additional information, which was unknown at the time of intial medwatch.There are warnings in the package insert that this type of event can occur.Under possible adverse effects, it 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.".

Event Description

A patient enrolled in a clinical study reported a right knee stitch abscess approximately 6 months post-implantation.It was further reported that patient's right knee was revised approximately 2 years post-implantation due to tibial loosening, limited range of motion, pain and weakness.During the procedure, the tibial bearing were removed and replaced.

• Brand Name: VGXP XP E1 TIB BRG RM 9X71
• 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: 5401214
• MDR Text Key: 37208169
• Report Number: 0001825034-2016-00285
• 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,Followup
• Report Date: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 195402
• Device Lot Number: 868530
• 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: 11/02/2013
• 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: 77 YR
• Patient Weight: 74