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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNICOMPARTMENTAL KNEE PHASE 3 FEMORAL SIZE LARGE; PROSTHESIS, KNEE

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BIOMET UK LTD. OXFORD UNICOMPARTMENTAL KNEE PHASE 3 FEMORAL SIZE LARGE; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Use of Device Problem (1670)
Patient Problem No Information (3190)
Event Date 01/01/2013
Event Type  Injury  
Manufacturer Narrative
This user facility is outside of the united states.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.".
 
Event Description
It was reported the patient enrolled in a clinical study and underwent a right revision procedure approximately five years post-implantation due to non-matching size screws used during initial procedure.All components were removed and replaced with total knee implants.
 
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Brand Name
OXFORD UNICOMPARTMENTAL KNEE PHASE 3 FEMORAL SIZE LARGE
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
Manufacturer (Section G)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK   CF31 3XA
Manufacturer Contact
daniel tilbury
waterton industrial estates
bridgend CF31 -3XA
UK   CF31 3XA
0441656655
MDR Report Key5995964
MDR Text Key56334884
Report Number3002806535-2016-00774
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 foreign,study
Reporter Occupation Physician
Type of Report Initial
Report Date 09/06/2016
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? Yes
Device Operator Physician
Device Expiration Date06/30/2018
Device Model NumberN/A
Device Catalogue Number154602
Device Lot Number1529581
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/06/2016
Initial Date FDA Received10/04/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/20/2008
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 Age56 YR
Patient Weight136
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