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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. UNKNOWN

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BIOMET FRANCE S.A.R.L. UNKNOWN Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative

This user facility is outside of the united states. The product identification necessary to review manufacturing history was not provided. Current information is insufficient to permit a conclusion as to the cause of the event. Event is being reported to fda on one medwatch since the limited information available indicates that a revision procedure occurred. Should additional information be received regarding the revision procedure, the complaint will be reassessed and, if warranted, further medwatch reports will be submitted.

 
Event Description

It was reported that patient underwent an unknown procedure on an unknown date. Subsequently, a revision procedure was performed on an unknown date due to unknown reasons. During the procedure, the monomer did not enter the cylinder. However, there was no patient injury and no delay in procedure. No further information has been provided.

 
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Brand NameUNKNOWN
Type of DeviceUNKNOWN
Manufacturer (Section D)
BIOMET FRANCE S.A.R.L.
plateau de lautagne bp75
valence cedex 26903
FR 26903
Manufacturer (Section G)
BIOMET FRANCE S.A.R.L.
plateau de lautagne bp75
valence cedex 26903
FR 26903
Manufacturer Contact
christophe mironneau
plateau de lautagne bp75
valence cedex 26903
FR   26903
0334757591
MDR Report Key5360967
MDR Text Key35694609
Report Number3006946279-2016-00001
Device Sequence Number1
Product Code JDY
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberPUNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 12/18/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/12/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device MODEL NumberN/A
Device Catalogue NumberUNKNOWN
Device LOT NumberUNKNOWN
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2015
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
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 01/12/2016 Patient Sequence Number: 1
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