BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ARPE STEM

    MDR report key: 8469039 · Received April 1, 2019

    Report

    Report Number
    0001825034-2019-01494
    Event Type
    Injury
    Date Received
    April 1, 2019
    Date of Event
    March 6, 2019
    Report Date
    April 4, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE WAS REPORTED UNDER THE INCORRECT MANUFACTURING SITE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. UNIQUE IDENTIFIER (UDI) #: N/A. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN ARPE NECK/HEAD, UNKNOWN ARPE CUP. EVENT OCCURRED IN (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 01492, 0001825034 - 2019 - 01493.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 1 YEAR POST IMPLANTATION, THE PATIENT UNDERWENT A REVISION OF A THUMB ARTHROPLASTY DUE TO PAIN, INSTABILITY, AND LOOSENING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264929 UNKNOWN ARPE STEM PROSTHESIS, THUMB KWG ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R