BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAESTRO TOTAL WRIST RADIAL STEM 6.0X40MM

    MDR report key: 7758249 · Received August 7, 2018

    Report

    Report Number
    0001825034-2018-04638
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    May 20, 2011
    Report Date
    August 7, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWJ
    PMA / PMN Number
    PK042032
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: 180120 MAESTRO, CAPITATE STEM 6X12MM, 303280; 180151 MAESTRO, RAD W/BRG 7X15 7.5 RT, 294070; 180103 MAESTRO, CARP PLATE 9X37, (B)(4), 697940; 180063 MAESTRO, CARPAL HEAD 7X15MM STD, 961010; 113846 TITANIUM, SCREW LOW PROF 5X30MM, 472030; 113843 TITANIUM, SCREW LOW PROF 5X15MM, 349570. THE COMPLAINT CANNOT BE CONFIRMED WITH LIMITED INFORMATION RECEIVED. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO DEVIATIONS OR ANOMALIES. ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 04639, 0001825034 - 2018 - 04641, 0001825034 - 2018 - 04644, 0001825034 - 2018 - 04648.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A WRIST REVISION DUE TO UNKNOWN REASONS FIVE YEARS POST PRIMARY SURGERY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596753 MAESTRO TOTAL WRIST RADIAL STEM 6.0X40MM PROSTHESIS, WRIST JWJ ZIMMER BIOMET, INC. N/A 635990

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R