MAUDE Adverse Event Report: BIOMET UK LIMITED OXFORD ANATOMIC BEARING LT LG SIZE 4 PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

It was reported a patient enrolled in a clinical study underwent initial left partial knee arthroplasty on (b)(6) 2008.During post-operative monitoring and testing, patient reported pain and instability.There has been no reported revision procedure to date.

Manufacturer Narrative

This tibial bearing is not 510(k) cleared for use with the cementless high flex partial knee system and does not require medical device reporting per 21 cfr part 803.Please disregard this manufacturer report number.

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 warnings, number 1 states, "improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components." under possible adverse effects, number 20 states, "persistent pain.".

• Brand Name: OXFORD ANATOMIC BEARING LT LG SIZE 4 PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LIMITED; waterton industrial estate; bridgend 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: 4790177
• MDR Text Key: 5804472
• Report Number: 0001825034-2015-02155
• 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: Foreign,Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2013
• Device Model Number: N/A
• Device Catalogue Number: 159555
• Device Lot Number: 1523988
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2008
• 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: 81 YR
• Patient Weight: 74