BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE HUMERAL BEARING

    MDR report key: 7947953 · Received October 9, 2018

    Report

    Report Number
    0001825034-2018-09191
    Event Type
    Injury
    Date Received
    October 9, 2018
    Date of Event
    December 20, 2016
    Report Date
    March 7, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MJT
    PMA / PMN Number
    PK080642
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. REVIEW OF THE OP NOTES FROM THIS REVISION NOTED THAT THE SHOULDER WAS ANTERIORLY DISLOCATED, WITH THE GLENOSPHERE BEING WELL-POSITIONED AND SECURE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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.

    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. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE PRODUCT CODE-PHX. UNIQUE IDENTIFIER (UDI) #: (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM # 115370, COMP RVS TRAY CO 44MM, LOT #163650; ITEM # 115310, COMP RVRS SHLDR GLNSP STD 36MM, LOT # 961680; ITEM # 180550, COMP LK SCR 3.5HEX 4.75X15 ST, LOT # 331030; ITEM # 180554, COMP LK SCR 3.5HEX 4.75X35 ST, LOT # 028240; ITEM # 010000589, COMP RVRS 25MM BSPLT HA+ADPTR, LOT # 017540; ITEM # 180550, COMP LK SCR 3.5HEX 4.75X15 ST, LOT # 135680; ITEM # 115396, COMP RVS CNTRL 6.5X30MM ST/RST, LOT # 391730; ITEM # 406669, STN PN THD TIP .125X2.5IN 2PK, LOT # 354400; ITEM # 113635, COMP PRIMARY STEM 15MM MINI, LOT # 231180. REPORT SOURCE: LEGAL NOTIFICATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 09190.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY TWO (2) WEEKS POST IMPLANTATION, THE PATIENT HAD PRESENTED TO THE CLINIC WITH A RIGHT PROSTHETIC SHOULDER DISLOCATION WITHOUT ANY TRAUMATIC EVENT, AND UNDERWENT A REVISION SURGERY. DURING THE REVISION, THE HUMERAL TRAY AND BEARING WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787268 COMPREHENSIVE REVERSE HUMERAL BEARING PROSTHESIS, SHOULDER MJT ZIMMER BIOMET, INC. N/A 884300

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R