BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL HUMERAL HEAD PROSTHESIS

    MDR report key: 19047353 · Received April 4, 2024

    Report

    Report Number
    0001825034-2024-00957
    Event Type
    Injury
    Date Received
    April 4, 2024
    Date of Event
    September 20, 2017
    Report Date
    August 14, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    PMA / PMN Number
    K060716
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG #: 115310, COMP RVRS SHLDR GLNSP STD 36MM, LOT #: 670930; CATALOG #: 115330, COMP RVRS SHDR GLEN BSPLT +HA, LOT #: 415440; CATALOG #: 180553, COMP LK SCR 3.5HEX 4.75X30 ST, LOT #: 541780; CATALOG #: 180553, COMP LK SCR 3.5HEX 4.75X30 ST, LOT #: 472190; CATALOG #: 180552, COMP LK SCR 3.5HEX 4.75X25 ST, LOT #: 593030; CATALOG #: 115397, COMP RVS CNTRL 6.5X35MM ST/RST, LOT #: 172790; CATALOG #: 180561, COMP NLK SCR 3.5HEX 4.75X35 ST, LOT #: 251830; CATALOG #: 180560, COMP NLK SCR 3.5HEX 4.75X30 ST, LOT #: 541780; CATALOG #: 113653, COMP PRIMARY STEM 13MM STD, LOT #: 921870; CATALOG #: 115370, COMP RVS TRAY CO 44MM, LOT #: 577900; CATALOG #: XL-115363, ARCOM XL 44-36 STD HMRL BRNG, LOT #: 355910 . H3: CUSTOMER HAS INDICATED, THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS ITS 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: 0001825034-2024-00955, 0001825034-2024-00956. H3 OTHER TEXT: PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 0

    (B)(4). THE EVENT WAS REASSESSED, AND IT WAS DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THEREFORE, THIS COMPONENT IS NOT REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED, PATIENT UNDERWENT LEFT REVERSE TOTAL SHOULDER APPROXIMATELY 8 YEARS AGO. SUBSEQUENTLY, ABOUT A YEAR LATER, THE PATIENT UNDERWENT A REVISION, DUE TO BONE EROSION (NOTCHING), HO AND POOR BASEPLATE POSITIONING. THE PATIENT RETAINED THE WELL FIXED STEM, BUT REVISED HUMERAL TRAY & BEARING. GLENOSPHERE COMPONENTS REVISED TO COMPETITOR PRODUCTS. NO FURTHER INFORMATION IS KNOWN.

    Description of Event or Problem · 0

    THE EVENT WAS REASSESSED, AND IT WAS DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THEREFORE, THIS COMPONENT IS NOT REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2334669 VERSA-DIAL HUMERAL HEAD PROSTHESIS EXTREMITIES IMPLANTS HSD ZIMMER BIOMET, INC. N/A 411920

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H SEE H10