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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN MAESTRO TOTAL WRIST PROSTHESIS, WRIST

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BIOMET ORTHOPEDICS UNKNOWN MAESTRO TOTAL WRIST PROSTHESIS, WRIST Back to Search Results
Model Number N/A
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Synovitis (2094)
Event Type  Injury  
Manufacturer Narrative
Current information is insufficient to permit conclusions as to the cause of the events. Event details and product identification were not provided for the patient mentioned in the journal article. The article was written by nydick, jason a. ; greenberg, scott m. ; stone, jeffrey d. ; williams, bailee; polikandriotis, john a. ; and hess, alfred v.
 
Event Description
It is reported that one patient developed synovitis as result of loose second metacarpal carpal non-locking screw. This required a synovectomy and screw removal.
 
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Brand NameUNKNOWN MAESTRO TOTAL WRIST
Type of DevicePROSTHESIS, WRIST
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
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6258036
MDR Text Key64988116
Report Number0001825034-2017-00178
Device Sequence Number1
Product Code JWJ
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 health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 01/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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 Received12/22/2016
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: 01/17/2017 Patient Sequence Number: 1
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