BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI TRAY STD COCR +0 OFFSET

    MDR report key: 11565617 · Received March 24, 2021

    Report

    Report Number
    0001822565-2021-00840
    Event Type
    Injury
    Date Received
    March 24, 2021
    Date of Event
    February 25, 2021
    Report Date
    August 19, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00887866231315
    PMA / PMN Number
    K181611
    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 HUMERAL TRAY WAS NOT PART OF THE PATIENT'S ISSUE, AND WAS SIMPLY REMOVED, AS REQUIRED, TO CONVERT THE PATIENT TO A HEMI-ARTHROPLASTY.

    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 HUMERAL TRAY WAS NOT PART OF THE PATIENT'S ISSUE, AND WAS SIMPLY REMOVED, AS REQUIRED, TO CONVERT THE PATIENT TO A HEMI-ARTHROPLASTY.

    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; CATALOG #: 118001, VERSA-DIAL/COMP TI STD TAPER, LOT # 429790. 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: 0001825034-2021-00865, 0001825034-2021-00866. 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
    460247 MINI TRAY STD COCR +0 OFFSET PROSTHESIS SHOULDER KWS ZIMMER BIOMET, INC. N/A 64396704 00887866231315

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R