BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY

    MDR report key: 7396838 · Received April 4, 2018

    Report

    Report Number
    0001825034-2018-02320
    Event Type
    Injury
    Date Received
    April 4, 2018
    Date of Event
    March 15, 2018
    Report Date
    April 2, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK113069
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: MFR#0001825034-2018-02315, MFR#0001825034-2018-02322, MFR#0001825034-2018-02324, MFR#0001825034-2018-02325, MFR#0001825034-2018-02326. CONCOMITANT PRODUCTS: COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING PNXL-115363 LN788490; COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE PN115310 LN785040; COMPREHENSIVE REVERSE SHOULDER PRIMARY MINI LENGTH STEM PN113634 LN169240; COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE BASEPLATE PN115330 LN364670; COMPREHENSIVE REVERSE SHOULDER VERSA-DIAL STANDARD ADAPTOR PN118001 LN940930; 115381 NAME: COMP RVS CNTRL SCR 6.5X25MM ST LOT: 843160; 180500 NAME: COMP LOCKING SCREW 4.75X15MM LOT: 618000; 180504 NAME: COMP LOCKING SCREW 4.75X35MM LOT: 045540; 180504 NAME: COMP LOCKING SCREW 4.75X35MM LOT: 990190; 180500 NAME: COMP LOCKING SCREW 4.75X15MM LOT: 276230; 405889 NAME: COMP RVS 2.7MM DIA DRL LOT: 740070; 405800 NAME: COMP. REV SHLDR 9 IN STEINMANN LOT: 850910. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD (DHR)WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO 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 · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL SHOULDER PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS SIX YEARS LATER. THE PATIENT'S TOTAL SHOULDER WAS EXPLANTED AND A SPACER WAS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239676 COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 243210

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R