MAUDE Adverse Event Report: BIOMET ORTHOPEDICS OXF ANAT BEARING LT MD SIZE 6 PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913)

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

Event Type  Injury  

Event Description

It was reported that patient underwent an initial left partial knee arthroplasty on (b)(6) 2009.Subsequently, patient was revised on (b)(6) 2012 due to bearing spinning.The tibial bearing was removed and replaced.A further revision procedure has been indicated due to bearing spinning; however, no revision procedure has been reported to date.

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 or deviation.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." this report is number 2 of 2 mdrs filed for the same event (reference 1825034-2015-03571 / 03572).

Manufacturer Narrative

This report is number 2 of 2 mdr's filed for the same event (reference 1825034-2015-03571 / 03572).

• Brand Name: OXF ANAT BEARING LT MD SIZE 6 PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET ORTHOPEDICS; waterton industrial estate; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET ORTHOPEDICS; waterton industrial estate; bridgend
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4974903
• MDR Text Key: 6076565
• Report Number: 0001825034-2015-03572
• 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

• Date FDA Received: 08/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 159550
• Device Lot Number: 2648100
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2012
• 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): Required Intervention