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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXF PKS ANAT MEN BRG UHMWPE RT LRG SZ 5; PROSTHESIS, KNEE

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BIOMET UK LTD. OXF PKS ANAT MEN BRG UHMWPE RT LRG SZ 5; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Date 09/23/2014
Event Type  Injury  
Event Description
It was reported that the patient underwent oxford knee surgery on (b)(6) 2013.Revision procedure was performed on (b)(6) 2014 due to infection.No further information has been received.
 
Manufacturer Narrative
The user facility is outside of the united states.No medwatch report was received.No product has been 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
OXF PKS ANAT MEN BRG UHMWPE RT LRG SZ 5
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 Key4184618
MDR Text Key5102967
Report Number3002806535-2014-00236
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,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 09/25/2014
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 Date11/30/2015
Device Model NumberN/A
Device Catalogue Number159584
Device Lot Number2189544
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/25/2014
Initial Date FDA Received10/20/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/15/2010
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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