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U.S. Department of Health and Human Services

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

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BIOMET ORTHOPEDICS UNKNOWN MAESTRO RADIAL COMPONENT PROSTHESIS, WRIST Back to Search Results
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Inflammation (1932); Synovitis (2094)
Event Type  Injury  
Manufacturer Narrative
Gasper, et al. "complications following partial and total wrist arthroplasty: a single-center retrospective review. " j hand surg am. Vol. 41 (january 2016). Pg. 47-53. 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. No medical records received; however, it is noted that the cementless construct utilized in this article study is off-label use. Additionally, the use of the maestro in the distal radial hemiarthroplasty construct is not an indicated use. The following sections could not be completed with the limited information provided: b3 - date of event - ni d2 - device product code - ni d4 - expiration date - ni d6 - date implanted - ni d7 - date explanted - ni e1 - initial reporter - authors of the article include jesse lou, patrick m. Kane, sidney m. Jacoby, a. Lee osterman, and randall w. Culp. H4 - manufacture date ¿ ni this report is number 3 of 3 mdrs filed for the same patient (reference 1825034-2016-05336/0001825034 - 2017 - 00503/0001825034 - 2017 - 00507).
 
Event Description
It is reported in a journal article that a patient underwent a wrist arthroplasty revision and a radical flexor tenosyovectony 36. 1 months post-implantation due to symptomatic loosening of the radial component noted with signs of synovitis. The distal radial component was removed and replaced with competitor product. No further information is available.
 
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Brand NameUNKNOWN MAESTRO 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 Key6372646
MDR Text Key68820027
Report Number0001825034-2017-00507
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 literature
Reporter Occupation
Type of Report Initial
Report Date 02/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received02/01/2017
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 NumberNI

Patient Treatment Data
Date Received: 03/02/2017 Patient Sequence Number: 1
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