BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAESTRO RADIAL STEM 4.5X40MM

    MDR report key: 9130210 · Received September 27, 2019

    Report

    Report Number
    0001825034-2019-04291
    Event Type
    Injury
    Date Received
    September 27, 2019
    Report Date
    November 25, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWJ
    PMA / PMN Number
    K042032
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS CONSIDERED CONFIRMED DUE TO THE PROVED X-RAYS THAT SHOWED LOOSENING OF THE RADIAL COMPONENT. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS CONSIDERED TO BE USER ERROR AS IT WAS KNOWN THAT THE PATIENT WAS A NURSE THAT LIFTED PATIENTS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-05314

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). (UDI): N/A. MEDICAL PRODUCT: CATALOG #: 180151, MAESTRO RAD W/BRG 7X15 7.5 RT, LOT # 922440; CATALOG #: 180351, VARIABLE LOCK SCREW 4.75X20MM, LOT # 748570; CATALOG #: 180363, MAESTRO TC CARPALHD 7X15MM STD, LOT # 527190; CATALOG #: 180352, VARIABLE LOCK SCREW 4.75X25MM, LOT # 551330; CATALOG #: 180363, MAESTRO TC CARPALHD 7X15MM STD, LOT # 527190; CATALOG #: 180321, MAESTRO TC CAPITATESTEM 6X15MM, LOT # 238690. THE CUSTOMER HAS NOT INDICATED WHETHER THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION OR NOT. ONCE THIS INFORMATION IS OBTAINED A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. UNKNOWN IF PRODUCT WILL BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS SCHEDULED TO BE GETTING A REVISION DUE TO THE RADIAL STEM BEING LOOSE IN THE CANAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921556 MAESTRO RADIAL STEM 4.5X40MM PROSTHESIS SHOULDER JWJ ZIMMER BIOMET, INC. N/A 181430

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R