MAUDE Adverse Event Report: BIOMET UK LTD OXF ANAT BRG LT SM SIZE 3 PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Mechanical Problem (1384)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

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.Remains implanted.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.¿.

Event Description

It was reported that the clinical patient underwent a left partial knee arthroplasty on an unknown date.Subsequently, patient experienced sharp pain in left knee, trouble bending or moving suddenly, and the knee feels it is locking up.No revision has been reported at this time.No further information has been provided.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

It was reported that the clinical patient underwent a left partial knee arthroplasty on (b)(6) 2011.Subsequently, patient experienced sharp pain in left knee, trouble bending or moving suddenly, and the knee feels it is locking up.No revision has been reported at this time.No further information has been provided.

• Brand Name: OXF ANAT BRG LT SM SIZE 3 PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD; waterton industrial estate; bridgend
• 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: 5517578
• MDR Text Key: 40929892
• Report Number: 0001825034-2016-00981
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2015
• Device Model Number: N/A
• Device Catalogue Number: 159540
• Device Lot Number: 2193637
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2010
• 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
• Patient Age: 47 YR