BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE PT HYBRID GLEN POST REGENEREX

    MDR report key: 9307715 · Received November 11, 2019

    Report

    Report Number
    0001825034-2019-05076
    Event Type
    Injury
    Date Received
    November 11, 2019
    Date of Event
    September 27, 2019
    Report Date
    April 30, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304459854
    PMA / PMN Number
    K060694
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.

    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). CONCOMITANT MEDICAL PRODUCTS: CATALOG #: 113954, MD HYBRID GLENOID BASE 4MM, LOT # 293790, CATALOG #: 406669, STN PN THD TIP .125X2.5IN 2PK, LOT # 745160, CATALOG #: 113633, COMP PRIMARY STEM 13MM MINI, LOT # 180300, CATALOG #: 118001, VERSA-DIAL/COMP TI STD TAPER, LOT # 497590, CATALOG #: 113046, VERSA-DIAL 46X24X47 HUM HEAD, LOT # 753240. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT IS UNKNOWN WHERE THE DEVICE IS. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 05038. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED AN INITIAL LEFT SHOULDER ARTHROPLASTY APPROXIMATELY A YEAR AGO. SUBSEQUENTLY A REVISION OCCURRED ABOUT 2 MONTHS AGO DUE TO A LOOSENING BASEPLATE AND BONE EROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1098813 COMPREHENSIVE PT HYBRID GLEN POST REGENEREX PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 724320 00880304459854

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R