BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS SHLDR GLNSP +6 36MM

    MDR report key: 11602941 · Received April 1, 2021

    Report

    Report Number
    0001825034-2021-00954
    Event Type
    Injury
    Date Received
    April 1, 2021
    Date of Event
    January 24, 2020
    Report Date
    August 25, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304532455
    PMA / PMN Number
    K080642
    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). CORRECTED: D1, D4 (ITEM, LOT, EXP DATE). D10 - MEDICAL PRODUCT: CATALOG#: 010000589, COMP RVRS 25MM BSPLT HA+ADPTR R, LOT#: 966260. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE PRODUCT WAS EVALUATED THROUGH MANUFACTURING REVIEW, HOWEVER, THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. A DEFINITIVE 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS PATIENT; PLEASE SEE ALL REPORTS ASSOCIATED WITH THIS EVENT: 0001825034-2021-00954 AND 0001825034-2021-02495.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: CATALOG #: 110031399, MINI HUMERAL TRAY STANDARD THICKNESS, LOT # 64396704. CATALOG #: 110031418, BEARING STANDARD 36 MM DIAMETER, LOT # 64343765. 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.

    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
    500991 COMP RVRS SHLDR GLNSP +6 36MM PROSTHESIS SHOULDER KWS ZIMMER BIOMET, INC. N/A 829820 00880304532455

    Patients

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