BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPR 6MM HUM FRACT STEM PPS

    MDR report key: 11800873 · Received May 10, 2021

    Report

    Report Number
    0001825034-2021-01422
    Event Type
    Injury
    Date Received
    May 10, 2021
    Date of Event
    March 4, 2021
    Report Date
    June 17, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304591530
    PMA / PMN Number
    K140652
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, G3, H2, H3, H6 REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT CODE: PHX. CONCOMITANT PRODUCTS: 115310 COMP RVRS SHLDR GLNSP STD 36MM 870560; 010000589 COMP RVRS 25MM BSPLT HA+ADPTR 241790; XL-115364 ARCOM XL 44-36 STD +3 HMRL BRG 096260; 115375 COMP RVS TRAY +5MM CO 44MM 018900. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT LOCATION IS UNKNOWN. 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 - 01418, 0001825034 - 2021 - 01420 , 0001825034 - 2021 - 01423, 0001825034 - 2021 - 01424.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT LEFT COMPREHENSIVE REVERSE SHOULDER PROCEDURE. THE PATIENT UNDERWENT A REVISION PROCEDURE THREE YEARS LATER DUE TO PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695297 COMPR 6MM HUM FRACT STEM PPS PROSTHESIS, SHOULDER PHX ZIMMER BIOMET, INC. N/A 456480 00880304591530

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R