BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVSR SHLDR GLNSP +3 36MM

    MDR report key: 9316558 · Received November 13, 2019

    Report

    Report Number
    0001825034-2019-04940
    Event Type
    Injury
    Date Received
    November 13, 2019
    Date of Event
    May 21, 2019
    Report Date
    November 13, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304475778
    PMA / PMN Number
    K080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# 010000589; COMP RVRS 25MM BSPLT HA+ADPTR; LOT# 296770, ITEM# 115395; COMP RVS CNTRL 6.5X25MM ST/RST; LOT# 522910, ITEM# 180553; COMP LK SCR 3.5HEX 4.75X30 ST; LOT# 602720, ITEM# 180553; COMP LK SCR 3.5HEX 4.75X30 ST; LOT# 042760, ITEM# 180554; COMP LK SCR 3.5HEX 4.75X35 ST; LOT# 878350, ITEM# 113613; COMP PRIMARY STEM 13MM MICRO; LOT# 904750, ITEM# 115378; COMP RVS TRAY +10MM CO 44MM; LOT# 800040, ITEM# XL-115364; ARCOM XL 44-36 STD +3 HMRL BRG; LOT# 247330. REPORT SOURCE: (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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 EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-02449, 0001825034-2019-04938, 0001825034-2019-04941, 0001825034-2019-04942, 0001825034-2019-04943, 0001825034-2019-04944, 0001825034-2019-04945, 0001825034-2019-04946.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY EIGHT MONTHS POST INITIAL DUE TO INFECTION. A SPACER MOLD WAS TEMPORARILY IMPLANTED AND REMOVED AT A LATER DATE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108792 COMP RVSR SHLDR GLNSP +3 36MM PROSTHESIS, EXTREMITIES KWS ZIMMER BIOMET, INC. N/A 020060 00880304475778

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R