MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT LG SIZE 4 PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problems Detachment Of Device Component (1104); Device Slipped (1584)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 08/13/2015

Event Type  Injury  

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 10 states, ¿loosening or migration of the implants can occur.¿.

Event Description

It was reported that the patient underwent a right partial knee arthroplasty on (b)(6) 2015.Subsequently, the patient was revised on (b)(6) 2015 due to poly dissociation.The tibial bearing was removed and replaced.

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.Requested but not returned by hospital.

• Brand Name: OXF ANAT BRG RT LG SIZE 4 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: 5019223
• MDR Text Key: 23631113
• Report Number: 0001825034-2015-03738
• 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
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 03/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 159583
• Device Lot Number: 785830
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2014
• 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: 78 YR