MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD ANATOMIC BEARING RT SM SIZE 3 PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problems Unexpected Therapeutic Results (1631); Insufficient Information (3190)

Patient Problems Inflammation (1932); Pain (1994); Burning Sensation (2146)

Event Type  Injury  

Event Description

It was reported that the patient underwent initial right knee arthroplasty on (b)(6) 2013.Subsequently, the patient has allegedly been experiencing pain and inflammation, and feels a rubbing/irritation in her knee since the procedure.No revision procedure has been indicated.The patient received a cortisone injection on an unknown date.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.

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 partial knee arthroplasty on (b)(6) 2013.Patient alleged pain, inflammation and a rubbing sensation in the knee.Patient further alleged that a second opinion was obtained from another surgeon who stated that there were "shards" in the knee.Radiographic analysis suggests femoral component loosening, but did not confirm the presence of "shards".There has been no reported revision procedure to date.

Manufacturer Narrative

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

Manufacturer Narrative

This follow-up report is being filed to correct information.Remains implanted.

• Brand Name: OXFORD ANATOMIC BEARING RT SM SIZE 3 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: 4358271
• MDR Text Key: 5119296
• Report Number: 0001825034-2014-09273
• 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: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 159568
• Device Lot Number: 2825482
• 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: 09/20/2012
• 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): Other
• Patient Age: 70 YR