BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT HYBRID GLEN POST REGENEREX

    MDR report key: 8603164 · Received May 13, 2019

    Report

    Report Number
    0001825034-2019-02076
    Event Type
    Injury
    Date Received
    May 13, 2019
    Date of Event
    April 18, 2019
    Report Date
    July 30, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K060694
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE 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 THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURER: FOREIGN-(B)(4). CONCOMITANT MEDICAL PRODUCTS: PART: 113053, LOT: 990650, VERSA-DIAL 50X21X57 HUM HEAD; PART: 113954, LOT: 410050, MD HYBRID GLENOID BASE 4MM; PART: 118001, LOT: 652590, VERSA-DIAL/COMP TI STD TAPER; PART: 113611, LOT :170140, COMP PRIMARY STEM 11MM MICRO. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL SHOULDER PROCEDURE ON (B)(6) 2018. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO COMPREHENSIVE ANATOMIC TO REVERSE SHOULDER ON (B)(6) 2019. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396515 PT HYBRID GLEN POST REGENEREX EXTREMITIES, IMPLANT KWS ZIMMER BIOMET, INC. N/A 760210

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R