MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD ANATOMIC BEARING LT SM SIZE 5 PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problems Material Erosion (1214); Migration or Expulsion of Device (1395); Device Slipped (1584)

Patient Problem Pain (1994)

Event Date 12/16/2014

Event Type  Injury  

Event Description

Patient reported to have undergone left partial knee arthroplasty on (b)(6) 2010.Subsequently, the patient alleged the onset of pain two years post-surgery and currently alleges loosening.There has been no reported revision procedure to date.

Manufacturer Narrative

Date of event unk.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: ¿loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity¿ persistent pain.¿.

Manufacturer Narrative

This follow-up report is being filed to relay information which was unknown at the time of the initial medwatch.

Event Description

Patient reported to have undergone left partial knee arthroplasty on (b)(6) 2010.The patient alleged the onset of pain two years post-surgery.Subsequently, the patient was revised on (b)(6) 2014 due to alleged loosening.The patient further reported that during the revision the surgeon noted significant wear of the implant but did not attribute it to anything.All partial knee components were removed and replaced with total knee components.

Manufacturer Narrative

The follow-up report is being filed to relay additional information that was unknown at the time of the initial medwatch.

Manufacturer Narrative

This follow-up report is being filed to correct information and to relay additional information, which was unknown at the time of the initial medwatch.

• Brand Name: OXFORD ANATOMIC BEARING LT SM SIZE 5 PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend 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: 4094540
• MDR Text Key: 4833389
• Report Number: 0001825034-2014-07709
• 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
• Report Date: 03/07/2016

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 Expiration Date: 04/30/2015
• Device Model Number: N/A
• Device Catalogue Number: 159542
• Device Lot Number: 2052396
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/09/2015
• Initial Date FDA Received: 09/16/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 10/17/2014; 01/16/2015; 04/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2010
• 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
• Patient Age: 48 YR