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

Model Number N/A

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091); Test Result (2695)

Event Date 07/22/2014

Event Type  Injury  

Event Description

It was reported that a patient enrolled in a clinical study underwent initial partial left knee arthroplasty on (b)(6) 2014.Subsequently, the patient was revised on (b)(6) 2014 due to pain and swelling.Blood tests revealed infection.During the revision procedure, irrigation, debridement, and placement of antibiotic beads occurred and the tibial bearing was replaced.

Manufacturer Narrative

Additional information: 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.There are warnings in the package insert that state that this type of event can occur: ¿early or late postoperative infection, and allergic reaction¿ and ¿persistent pain¿.

Manufacturer Narrative

This follow-up report is being filed to correct information.Product location unknown.

• Brand Name: OXFORD ANATOMIC BEARING LT SM SIZE 3 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: 4099585
• MDR Text Key: 15810117
• Report Number: 0001825034-2014-07794
• 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: Study,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: 09/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/28/2019
• Device Model Number: N/A
• Device Catalogue Number: 159540
• Device Lot Number: 948200
• 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: 03/01/2014
• 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: 50 YR
• Patient Weight: 69