MAUDE Adverse Event Report: BIOMET ORTHOPEDICS OXF UNI TIB TRAY SZA RM/LL PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Device Slipped (1584)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 10/13/2014

Event Type  Injury  

Event Description

It was reported that patient underwent right partial knee arthroplasty on (b)(6) 2014.Subsequently, patient was revised on (b)(6) 2014 due to a loose tibial tray.All components were removed and a total knee system was implanted.

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 related to the event.Examination of returned device found no evidence of product non-conformance.During the evaluation, it was noted there was little to no interdigitation shown on the cement with the tibial tray.The limited interdigitation was most likely caused by the parts applied with cement sitting too long prior to implantation.This caused the cement to start setting before it came into contact with bone, limiting the interdigitation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: "loosening, migration, or fracture of the implants can occur due to loss of fixation, trauma, malalignment, malposition, non-union, bone resorption, excessive weight, and/or excessive unusual and/or awkward movement and/or activity.".

Manufacturer Narrative

• Brand Name: OXF UNI TIB TRAY SZA RM/LL PMA
• 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: 4274721
• MDR Text Key: 21881726
• Report Number: 0001825034-2014-08775
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 154719
• Device Lot Number: 867250
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2013
• 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: 60 YR