BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVS CNTRL 6.5X25MM ST/RST

    MDR report key: 9540270 · Received January 2, 2020

    Report

    Report Number
    0001825034-2020-00044
    Event Type
    Injury
    Date Received
    January 2, 2020
    Date of Event
    July 15, 2019
    Report Date
    May 20, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K132239
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    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. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). UDI# (B)(4). CONCOMITANT MEDICAL PRODUCTS: 010000589 COMP RVRS 25MM BSPLT HA+ADPTR R 973360, 115310 COMP RVRS SHLDR GLNSP STD 36MM 122300, 113650 COMP PRIMARY STEM 10MM STD 170560, XL-115363 ARCOM XL 44-36 STD HMRL BRNG RING 152490. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. 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 - 00045, 0001825034 - 2020 - 00046, 0001825034 - 2020 - 00047, 0001825034 - 2020 - 00048.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130 COMP RVS CNTRL 6.5X25MM ST/RST PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. 819900

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R