MAUDE Adverse Event Report: BIOMET UK LIMITED OXFORD ANATOMIC BEARING LT MD SIZE 3 PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Device Slipped (1584); Malposition of Device (2616)

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

Event Date 06/03/2015

Event Type  Injury  

Event Description

It was reported that patient underwent initial left partial knee arthroplasty on (b)(6) 2013.Subsequently, patient was revised on (b)(6) 2015 due to loosening and spinning of the tibial bearing.The tibial bearing was removed and replaced.

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.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, number 10 states, "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity." device availability - the device is reported to be available for evaluation; however, it has not been received by biomet orthopedics to date.In the event that the device is received and evaluated, a follow up report will be sent to the fda to provide results.

Manufacturer Narrative

The follow-up report is being filed to relay additional information that was unknown at the time of the initial medwatch.(b)(4).Component migration - evaluation of the returned device found that it most likely left biomet conforming.The exact cause of the spinning cannot be determined.

Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance.The root cause of the event could not be determined.

• Brand Name: OXFORD ANATOMIC BEARING LT MD SIZE 3 PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LIMITED; waterton industrial estate; bridgend
• 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: 4880160
• MDR Text Key: 6258822
• Report Number: 0001825034-2015-02728
• 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: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 159547
• Device Lot Number: 2790938
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/03/2015
• Initial Date FDA Received: 06/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2012
• 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: 46 YR