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U.S. Department of Health and Human Services

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

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BIOMET UK LTD. OXF ANAT BRG LT MD SIZE 3 PMA; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Mechanical Problem (1384); Unstable (1667); Noise, Audible (3273)
Patient Problem Pain (1994)
Event Type  Injury  
Event Description
It was reported a patient enrolled in a clinical study underwent a left partial knee arthroplasty on (b)(6) 2007.Subsequently, patient underwent injections due to pain, instability and implant popping.There has been no reported revision procedure to date.
 
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 it 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.".
 
Manufacturer Narrative
This follow-up report is being filed to correct information.
 
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Brand Name
OXF ANAT BRG LT MD SIZE 3 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 Key4047332
MDR Text Key4908768
Report Number0001825034-2014-07424
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PP010014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date05/31/2012
Device Model NumberN/A
Device Catalogue Number159547
Device Lot Number1327866
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/30/2014
Initial Date FDA Received08/29/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/05/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/24/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight107
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