MAUDE Adverse Event Report: BIOMET UK LTD OXF ANAT BRG LT MD SIZE 6 PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problems Unstable (1667); Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091); Ambulation Difficulties (2544)

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 20 states, "persistent pain." 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.".

Event Description

It was reported that patient enrolled in a clinical study and underwent a left partial knee arthroplasty on (b)(6) 2011.During post-operative monitoring and testing, swelling, instability, limping, and moderate pain increased by bending, walking and standing were noted.These findings were found during follow up testing.There has been no reported revision procedure to date.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.

Event Description

It was reported that patient enrolled in a clinical study and underwent a left partial knee arthroplasty on (b)(6) 2011.During post-operative monitoring and testing, swelling and moderate pain increased by bending, walking and standing were noted.There has been no reported revision procedure to date.

• Brand Name: OXF ANAT BRG LT MD SIZE 6 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: 5522711
• MDR Text Key: 41049563
• Report Number: 0001825034-2016-00974
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2012
• Device Model Number: N/A
• Device Catalogue Number: 159550
• Device Lot Number: 1327916
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2007
• 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): Other
• Patient Age: 56 YR