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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PKS MEN BEARING UHMWPE MED SZ 3; PROSTHESIS, KNEE

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BIOMET UK LTD. OXFORD PKS MEN BEARING UHMWPE MED SZ 3; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Naturally Worn (2988)
Patient Problem No Code Available (3191)
Event Date 04/23/2014
Event Type  Injury  
Event Description
It was reported that patient underwent bilaterial knee surgery on (b)(6) 2002.Revision procedure was performed on (b)(6) 2014 due to bearing wear.No further information was received.
 
Manufacturer Narrative
The user facility is outside of the united states.No medwatch report was received.No product was returned.Current information is insufficient to permit a conclusion as to the cause of the event.No further complications have been reported.
 
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Brand Name
OXFORD PKS MEN BEARING UHMWPE MED SZ 3
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
sian rogers
waterton industrial estates
bridgend CF31 -3XA
UK   CF31 3XA
0441656655
MDR Report Key3832913
MDR Text Key22137200
Report Number3002806535-2014-00134
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
PP010014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/28/2014
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 Health Professional
Device Expiration Date04/30/2005
Device Model NumberN/A
Device Catalogue Number154626
Device Lot Number376502
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/28/2014
Initial Date FDA Received05/27/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/03/2000
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;
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