MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ D LM PMA; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Test Result (2695); No Information (3190)

Event Date 06/18/2014

Event Type  Injury  

Event Description

It was reported that patient underwent a partial knee arthroplasty on (b)(6), 2013.Subsequently, patient underwent a revision procedure on (b)(6), 2014 due to aseptic loosening of the tibial tray.All components were removed and patient was converted to a total knee.A review of the invoice history confirmed the surgery date; however, a revision invoice history could not be located to confirm which components were removed and replaced.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.There are warnings in the package insert that state that these types of events can occur: under possible adverse effects, number 10 states, "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.".

Manufacturer Narrative

This follow-up report is being filed to correct information.Product location unknown.

Manufacturer Narrative

This follow-up report is being filed to correct to remove "(b)(4).".

• Brand Name: OXF UNI TIB TRAY SZ D LM PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend, south wales IN CF31 3XA; UK CF31 3XA
• 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: 3947881
• MDR Text Key: 4641813
• Report Number: 0001825034-2014-06318
• 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,Followup
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 154724
• Device Lot Number: 630000
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2013
• 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