BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM MOD HEAD COCR STD NECK

    MDR report key: 7633580 · Received June 25, 2018

    Report

    Report Number
    0001825034-2018-04220
    Event Type
    Injury
    Date Received
    June 25, 2018
    Date of Event
    May 16, 2018
    Report Date
    October 2, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK911684
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PATIENT DOB ON UNKNOWN DAY IN 1960. CONCOMITANT MEDICAL PRODUCTS: ITEM # 010000734, LINER, LOT # 3940108, ITEM # UNK, HIP-UNKNOWN-STEMS-UNK, LOT # UNK, ITEM # 010000666, CUP, LOT # 6151352. THE EVENT OCCURRED IN (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-04219, 0001825034-2018-04220.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUFFERED FROM A DISLOCATION APPROXIMATELY ONE WEEK POST IMPLANTATION. A CLOSED REDUCTION PROCEDURE WAS PERFORMED AND THE MALFUNCTION WAS RESOLVED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477069 32MM MOD HEAD COCR STD NECK HIP PROSTHESIS JDI ZIMMER BIOMET, INC. N/A J6155848

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R