BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMP RVRS SHDR GLEN BSPLT +HA

    MDR report key: 8804940 · Received July 18, 2019

    Report

    Report Number
    0001825034-2019-03115
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    July 5, 2019
    Report Date
    September 11, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    K080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). PROCODE: PHX. CONCOMITANT MEDICAL PRODUCTS: 118001, UNKNOWN LOT, VERSA-DIAL/COMP TI STD TAPER; 115330, UNKNOWN LOT, COMP RVRS SHDR GLEN BSPLT +HA; 115316, UNKNOWN LOT, COMP RVRS SHLDR GLNSP +6 36MM. REPORT SOURCE: FOREIGN COUNTRY: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO DEVICE REMAINS IMPLANTED. 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: 0001825034-2019-03114.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT¿S SHOULDER WAS REVISED APPROXIMATELY 2 YEARS POST IMPLANTATION DUE TO PAIN AND DISASSOCIATION OF THE TAPER FROM THE BASEPLATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598647 COMP RVRS SHDR GLEN BSPLT +HA PROSTHESIS, SHOULDER PHX ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R