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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD IMPLANTS; PROSTHESIS, KNEE

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BIOMET UK LTD. UNKNOWN OXFORD IMPLANTS; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Naturally Worn (2988)
Patient Problem No Code Available (3191)
Event Date 07/17/2014
Event Type  Injury  
Event Description
It was reported that patient underwent primary knee surgery on an unknown date.Revision procedure was performed on (b)(6), 2014 due to wear.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
UNKNOWN OXFORD IMPLANTS
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 Key4036817
MDR Text Key4879564
Report Number3002806535-2014-00188
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 07/30/2014
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 Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/30/2014
Initial Date FDA Received08/26/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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