MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT MD SIZE 5 PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problems Contamination (1120); Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 07/03/2014

Event Type  Injury  

Event Description

It was reported that patient underwent a partial knee arthroplasty on (b)(6) 2014.Subsequently, patient underwent an irrigation and debridement procedure on (b)(6) 2014 due to suspected infection.During the procedure, the bearing was removed and replaced.A review of the invoice history confirmed the initial surgery date; however, an invoice could not be located to confirm the revision procedure and which components were removed and replaced.

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.

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.Review of sterilization certification confirms device was sterilized in accordance with iso 11137-2.Discarded.

• Brand Name: OXF ANAT BRG LT MD 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: 3963510
• MDR Text Key: 4622092
• Report Number: 0001825034-2014-06513
• 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: 03/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 159549
• Device Lot Number: 406360
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2013
• 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