MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI TIBIAL TRAY SZ C LM PMA; PARTIAL KNEE

Model Number N/A

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 02/17/2015

Event Type  Injury  

Event Description

Patient reported to have undergone partial knee arthroplasty on (b)(6) 2012.Patient alleges that a revision procedure is planned due to mechanical loosening; however, no revision has been reported to date.

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 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." event is being reported to fda on one medwatch as the limited information available indicates that a revision procedure is needed.Should additional information be received regarding a revision procedure, the complaint will be reassessed and further medwatch reports will be submitted, if necessary.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-00747 & 1825034-2015-01474).

Event Description

Patient reported to have undergone partial knee arthroplasty on (b)(6) 2012.Subsequently, patient was revised on (b)(6) 2015 due to mechanical loosening.All components were removed and replaced.

Manufacturer Narrative

This follow-up report is being filed to correct information.This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-00747 & 1825034-2015-01474).Product location unknown.

• Brand Name: OXFORD UNI TIBIAL TRAY SZ C LM PMA
• Type of Device: PARTIAL 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: 4553880
• MDR Text Key: 5521463
• Report Number: 0001825034-2015-00747
• 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: Consumer,consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 154722
• Device Lot Number: 2448192
• 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: 06/16/2011
• 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