BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STEM INSERTER

    MDR report key: 7332671 · Received March 12, 2018

    Report

    Report Number
    0001825034-2018-01705
    Event Type
    Injury
    Date Received
    March 12, 2018
    Date of Event
    February 11, 2018
    Report Date
    February 8, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT PRODUCT(S): ITEM NUMBER: 12-162613, ITEM NAME: STANDARD FEMORAL STEM, LOT #: 770520. ITEM NUMBER: 00223200228, ITEM NAME: CERCLAGE CABLE WITH CRIMP, LOT #: 63820962. ITEM NUMBER: 00223200228, ITEM NAME: CERCLAGE CABLE WITH CRIMP, LOT #: 63775363. ITEM NUMBER: 00223200228, ITEM NAME: CERCLAGE CABLE WITH CRIMP, LOT #: 63820962. ITEM NUMBER: 00223200228, ITEM NAME: CERCLAGE CABLE WITH CRIMP, LOT #: 63827903. ITEM NUMBER: 00223200228, ITEM NAME: CERCLAGE CABLE WITH CRIMP, LOT #: 63820962. ITEM NUMBER: 00223200301, ITEM NAME: BONE PLATE, LOT #: 61219708. ITEM NUMBER: 00223200318, ITEM NAME: CABLE FOR BONE PLATE, LOT #: 63377420. ITEM NUMBER: 00223200318, ITEM NAME: CABLE FOR BONE PLATE, LOT #: 62235733. ITEM NUMBER: X170311, ITEM NAME: INTEGRAL FEMORAL STEM, LOT #: 469440. ITEM NUMBER: 163662, ITEM NAME: FEMORAL HEAD, LOT #: 007270. ITEM NUMBER: 11-165220, ITEM NAME: RINGLOC BI-POLAR CUP, LOT #: 062900. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 01704.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL HIP ARTHROPLASTY THE STEM WOULD NOT ASSEMBLE WITH THE STEM INSERTER. MULTIPLE SCREWS WERE ATTEMPTED TO BE USED TO ASSEMBLE THE DEVICES; HOWEVER, THEY FAILED TO ATTACH. THE SURGEON ATTEMPTED TO INSERT THE STEM INTO THE FEMORAL CANAL WITHOUT BEING ASSEMBLED TO THE INSERTER, BUT THE CEMENT HAD ALREADY BEGUN HARDENING AND THE STEM WAS STUCK HALFWAY DOWN THE CANAL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT STEM. SURGERY WAS DELAYED APPROXIMATELY 6 HOURS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176071 UNKNOWN STEM INSERTER PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention