BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CR PROLONG 36MM BRNG STD

    MDR report key: 12214394 · Received July 22, 2021

    Report

    Report Number
    0001822565-2021-02053
    Event Type
    Injury
    Date Received
    July 22, 2021
    Date of Event
    January 24, 2020
    Report Date
    August 20, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K181611
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UPDATED: D4 (UDI). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: CATALOG #: 110031399, MINI HUMERAL TRAY STANDARD THICKNESS, LOT # 64396704. CATALOG #: 010000589, COMP RVRS 25MM BSPLT HA+ADPTR R, LOT # 966260. CATALOG #: 113625, COMP PRIMARY STEM 5MM MINI, LOT # 434380. CATALOG #: 115316, COMP RVRS SHLDR GLNSP +6 36MM, LOT # 829820. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL SURGERY APPROXIMATELY 1.5 YEARS AGO. SUBSEQUENTLY, ABOUT 1 MONTH LATER, THE PATIENT HAD A REVISION DUE TO DISLOCATION. THE PATIENT IS WHEELCHAIR BOUND, CHRONIC DISLOCATOR PATIENT, AND HAS ANATOMY ISSUES. THE DOCTOR DIDN¿T THINK HE COULD DO A REVERSE, HOWEVER WHEN HE WENT IN, HE GOT THE BASEPLATE HUNG, PATIENT WAS DOING WELL, THEN DISLOCATED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1106762 CR PROLONG 36MM BRNG STD PROSTHESIS SHOULDER KWS ZIMMER BIOMET, INC. N/A 64343765

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10.