MAUDE Adverse Event Report: BIOMET U.K LTD OXFORD ANATOMIC BEARING LT MD SIZE 3; PROSTHESIS, KNEE

Model Number N/A

Device Problem Collapse (1099)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Patient reported to have undergone partial knee arthroplasty on (b)(6) 2011.Patient further alleges that he is experiencing pain and issues with knee buckling.There has been no reported revision procedure to date.Additional information provided in a review of invoice history confirms the initial procedure 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 20 states, ¿persistent pain.¿.

• Brand Name: OXFORD ANATOMIC BEARING LT MD SIZE 3
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET U.K LTD; waterton industrial estate; bridgend; south wales cf31 3xa, great britan ; UK
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3651448
• MDR Text Key: 4353007
• Report Number: 0001825034-2014-01244
• 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
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2015
• Device Model Number: N/A
• Device Catalogue Number: 159547
• Device Lot Number: 2131828
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2010
• 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