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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN EXTREMITY PROSTHESIS, EXTREMITY

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BIOMET ORTHOPEDICS UNKNOWN EXTREMITY PROSTHESIS, EXTREMITY Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Fistula (1862)
Event Type  Injury  
Manufacturer Narrative
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 as the limited information available indicates that a revision procedure is (or may be) needed. Should additional information be received regarding a revision procedure, the complaint will be reassessed and further medwatch reports will be submitted, if necessary.
 
Event Description
A right elbow revision procedure has been indicated due to a fistula; however, no revision procedure has been reported to date.
 
Manufacturer Narrative
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
 
Event Description
A right elbow revision procedure has been indicated due to a fistula; however, no revision has been reported to date and competitor products will be implemented.
 
Manufacturer Narrative
Upon reassessment of the reported event, it was determined to not be reportable. A revision has been indicated due to patient anatomy and is not related to a product issue.
 
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Brand NameUNKNOWN EXTREMITY
Type of DevicePROSTHESIS, EXTREMITY
Manufacturer (Section D)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
megan haas
56 e. bell drive
warsaw, IN 46582
5743726700
MDR Report Key5961033
MDR Text Key55106836
Report Number0001825034-2016-03720
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
PNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/21/2016
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: 09/19/2016 Patient Sequence Number: 1
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