BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR FEMORAL HEAD

    MDR report key: 7273795 · Received February 15, 2018

    Report

    Report Number
    0001822565-2018-00824
    Event Type
    Injury
    Date Received
    February 15, 2018
    Date of Event
    January 16, 2018
    Report Date
    February 28, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK936044
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CMP-(B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE ALSO SEE ASSOCIATED REPORT(S): 0001822565-2018-00825, 0001825034-2018-00907. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN PART/LOT; FEMORAL STEM; 11-103562 UNIV RNGLC SHL 62MM/L24, LOT 176070; 11-105924 ARCOM 32MM RNGLOC LNR HWALL 24, LOT 211880. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED AN MDR SHOULD NOT HAVE BEEN FILED UNDER THE CURRENT MFR NUMBER. THIS EVENT WILL BE REPORTED ON 0002648920-2018-00154.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED APPROXIMATELY 15 YEARS POST IMPLANTATION DUE TO PAIN. THE STEM WAS REMOVED, AND THE CUP WAS RETAINED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115933 COCR FEMORAL HEAD PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 60017229

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R