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U.S. Department of Health and Human Services

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

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BIOMET ORTHOPEDICS UNKNOWN MAESTRO WRIST RADIAL COMPONENT PROSTHESIS, WRIST Back to Search Results
Model Number N/A
Device Problems Failure To Adhere Or Bond (1031); Migration or Expulsion of Device (1395)
Patient Problems Cyst(s) (1800); Pain (1994); Loss of Range of Motion (2032)
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 following could not be completed with the limited information provided. Date of event ¿ ni , device product code ¿ ni, expiration date ¿ ni , date implanted ¿ ni , date explanted ¿ ni , initial reporter - the article was written by culp, randall w. ; bachoura, abdo; gelman, scott e. ; and jacoby, sidney m. , manufacture date ¿ ni. (b)(4).
 
Event Description
Information was received based on review of a journal article titled, " proximal row carpectomy combined with wrist hemiarthroplasty " which aimed to present early experience with proximal row carpectomy (prc) combined with distal radius hemiarthroplasty using the maestro wrist reconstructive system radial component, manufactured by legacy biomet from april 2009 to june 2010. A competitor product was used from september 2010 onwards. Seventeen (17) patients were identified in the article that underwent proximal row carpectomy combined with distal radius hemiarthroplasty with a maestro radial component on an unknown date. Mean postoperative flexion, extension, and grip strength were all less than preoperative levels. It is reported that a (b)(6) male with a history of slac iii wrist underwent left wrist arthroplasty. At the 12 month followup, patient reported pain. At the 15 month followup, radiograph findings included cyst formation in the hamate, capitate, and distal radius. The patient was revised for aseptic loosening secondary to poly disease shortly afterward. No further information is available.
 
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Brand NameUNKNOWN MAESTRO WRIST RADIAL COMPONENT
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 Key6367739
MDR Text Key68661096
Report Number0001825034-2017-01254
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 02/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2017
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 Received02/03/2017
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: 03/01/2017 Patient Sequence Number: 1
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