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U.S. Department of Health and Human Services

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

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BIOMET ORTHOPEDICS UNKNOWN EXPLOR ELBOW PROSTHESIS, EXTREMITY Back to Search Results
Model Number N/A
Device Problem Detachment Of Device Component (1104)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
Current information is insufficient to permit conclusions as to the cause of the events. Event details and product identification was not provided for the patient mentioned in the journal article. Initial reporter - the article was written by roger e. Wiltfong, raymond k. Wurapa, and james c. Cassandra. Device location unknown.
 
Event Description
Information was received based on review of a journal article titled, " failure of a unipolar radial head prosthesis" which aimed to orthopedic surgeons the many options when considering radial head replacement implants and should be aware of the potential complications of each. The authors present this case to show one potential complication of unipolar prosthetic radial head implant arthroplasty. A patient was identified in the article that underwent an elbow arthroplasty on an unknown date. Subsequently, the patient experienced disassociation of the radial head. There has been no further information provided and the patient outcome is unknown.
 
Manufacturer Narrative
This follow-up report is being filed to relay corrected information.
 
Event Description
Information was received based on review of a journal article titled, " failure of a unipolar radial head prosthesis" which aimed to orthopedic surgeons the many options when considering radial head replacement implants and should be aware of the potential complications of each. The authors present this case to show one potential complication of unipolar prosthetic radial head implant arthroplasty. Two patients identified in the article underwent elbow arthroplasties on unknown dates. Subsequently, the patients experienced disassociation of the radial head. There has been no further information provided and the patients' outcome is unknown.
 
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Brand NameUNKNOWN EXPLOR ELBOW
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 Key5908666
MDR Text Key53279653
Report Number0001825034-2016-03352
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2016
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/22/2016
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: 08/26/2016 Patient Sequence Number: 1
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