BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS SHLDR GLNSP +6 36MM

    MDR report key: 11565588 · Received March 24, 2021

    Report

    Report Number
    0001825034-2021-00866
    Event Type
    Injury
    Date Received
    March 24, 2021
    Date of Event
    February 25, 2021
    Report Date
    July 8, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    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

    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 SUBMITTED IN ERROR.

    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). MEDICAL PRODUCT: CATALOG #: 110031399, MINI TRAY STD COCR +0 OFFSET, LOT # 64396704; CATALOG #: 113046, VERSA-DIAL 46X24X47 HUM HEAD, LOT # 686720. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2021-00840, 0001825034-2021-00865. DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS IS THE SECOND REVISION, AND THE PATIENT IS A CHRONIC DISLOCATOR PATIENT AND IS WHEELCHAIR BOUND. SHE HAS HAD MULTIPLE SURGERIES. THIS REVISION SHE WAS REVISED TO A HEMI. THE GLENOSPHERE WAS EXPLANTED THAT DISASSOCIATED FROM BASEPLATE. THE BASEPLATE AND HUMERAL TRAY WERE EXPLANTED. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458987 COMP RVRS SHLDR GLNSP +6 36MM PROSTHESIS SHOULDER KWS ZIMMER BIOMET, INC. N/A 829820

    Patients

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