BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM COCR MOD HD +6MM NO SKIRT

    MDR report key: 7926462 · Received October 2, 2018

    Report

    Report Number
    0001825034-2018-09355
    Event Type
    Injury
    Date Received
    October 2, 2018
    Date of Event
    May 16, 2018
    Report Date
    October 2, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK974558
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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. PATIENT DOB ON UNKNOWN DAY IN (B)(6). (B)(4). 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.

    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
    766978 32MM COCR MOD HD +6MM NO SKIRT HIP PROSTHESIS JDI ZIMMER BIOMET, INC. N/A 260900

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R