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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI FEMORAL MD; PARTIAL KNEE
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BIOMET UK LTD. OXFORD UNI FEMORAL MD; PARTIAL KNEE Back to Search Results
Model Number N/A
Device Problems Device Slipped (1584); Naturally Worn (2988)
Patient Problem No Code Available (3191)
Event Date 01/27/2015
Event Type  Injury  
Event Description
It was reported that patient underwent left partial knee arthroplasty on (b)(6) 2009.Subsequently, patient was revised on (b)(6) 2015 due to femoral loosening and polyethelyne liner wear.The femur, tibial tray and bearing were removed and patient underwent a total left knee conversion.
 
Manufacturer Narrative
Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: ¿loosening, of the implants can occur due to loss of fixation, non-union, bone resorption¿, ¿muscle and fibrous tissue laxity or excessive activity can also contribute to these conditions¿ and ¿wear and / or deformation of articulating surfaces.¿ this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015- 00658 / 00659).
 
Manufacturer Narrative
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Examination of returned device found no evidence of product non-conformance.Dimensional evaluation found component to be within appropriate design specification.During the evaluation, it was noted the root cause of the event was most likely due lack of bone cement, however examination of returned device was inconclusive.
 
Event Description
It was reported that patient underwent left partial knee arthroplasty on (b)(6) 2009.Subsequently, patient was revised on (b)(6) 2015 due to femoral loosening and polyethelyne liner wear.The femur, tibial tray, and bearing were removed and patient underwent a total left knee conversion.Additional information received in operative report noted patient was revised on (b)(6) 2015 due to femoral loosening, pain and loss of function.Operative report further noted synovitis, broken cement, fibrous tissue, and resorption of the femoral condyle.
 
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.This report is number 1 of 2 mdr's filed for the same event (reference 1825034-2015- 00658 / 00659).
 
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Brand Name
OXFORD UNI FEMORAL MD
Type of Device
PARTIAL 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 Key4538177
MDR Text Key5513218
Report Number0001825034-2015-00658
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 Health Professional,Company Representative,company representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 03/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date03/31/2019
Device Model NumberN/A
Device Catalogue Number154601
Device Lot Number1677905
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/13/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received03/04/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/23/2009
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) Hospitalization; Required Intervention;
Patient Age68 YR
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