BEUDAMED
    FDA Adverse Event Death Summary report: N

    FEMORAL STEM 12/14 NECK TAPER EXT. OFFSET SIZE 3 180 MM STEM LENGTH

    MDR report key: 8013538 · Received October 29, 2018

    Report

    Report Number
    0002648920-2018-00761
    Event Type
    Death
    Date Received
    October 29, 2018
    Date of Event
    August 13, 2014
    Report Date
    February 8, 2019
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JDI
    PMA / PMN Number
    K960658
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: 00801802802, ITEM NAME: FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER , LOT #: 62611498, ITEM NUMBER: 3003940002, ITEM NAME: REFOBACIN BONE CEMENT R 2X40G, LOT #: 228BAH2606, ITEM NUMBER: RM 4901 000 2, ITEM NAME: ORTHODYNAMICS ACETABULAR CUP, LOT #: 1312072A, ITEM NUMBER: RM 5110 003 2, ITEM NAME: ORTHODYNAMIC ACETABULAR LINER, LOT #: 1311332A. (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0002648920 - 2018 - 00760. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A RIGHT HIP PRIMARY REPLACEMENT. SUBSEQUENTLY, PATIENT EXPIRED DUE TO UNKNOWN REASONS APPROXIMATELY 3 MONTHS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854432 FEMORAL STEM 12/14 NECK TAPER EXT. OFFSET SIZE 3 180 MM STEM LENGTH PROSTHESIS, HIP JDI ZIMMER MANUFACTURING B.V. N/A 62498379

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death