BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVS TRAY +10MM CO 44MM

    MDR report key: 9983840 · Received April 21, 2020

    Report

    Report Number
    0001825034-2020-01712
    Event Type
    Injury
    Date Received
    April 21, 2020
    Report Date
    April 28, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304543195
    PMA / PMN Number
    K113069
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG #: 115330, COMP RVRS SHDR GLEN BSPLT +HA, LOT # 972880, CATALOG #: 115395, COMP RVS CNTRL 6.5X25MM ST/RST, LOT # 576860, CATALOG #: 180550, COMP LK SCR 3.5HEX 4.75X15 ST, LOT # 278060, CATALOG #: 180551, COMP LK SCR 3.5HEX 4.75X20 ST, LOT # 563990, CATALOG #: 115320, COMP RVRS SHLDR GLNSP STD 41MM, LOT # 656860, CATALOG #: 180555, COMP LK SCR 3.5HEX 4.75X40 ST, LOT # 954060, CATALOG #: 180552, COMP LK SCR 3.5HEX 4.75X25 ST, LOT # 324510, CATALOG #: 113657, COMP PRIMARY STEM 17MM STD, LOT # 674420, CATALOG #: EP-115396, E1 44-41 STD HMRL BRNG, LOT # 549440. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-01710, 0001825034-2020-01711. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT SHOULDER REVISION ABOUT TWO (2) MONTHS AGO. PATIENT IS EXPERIENCING AN INFECTION AND IS IN THE RECOVERY PHASE FROM THIS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445862 COMP RVS TRAY +10MM CO 44MM PROSTHESIS SHOULDER KWS ZIMMER BIOMET, INC. N/A 080640 00880304543195

    Patients

    Seq Age Sex Outcome Treatment
    1 Other