BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPT PETITE FEMORAL COMPONENT

    MDR report key: 5917625 · Received August 31, 2016

    Report

    Report Number
    0002648920-2016-01023
    Event Type
    Injury
    Date Received
    August 31, 2016
    Date of Event
    August 4, 2016
    Report Date
    January 11, 2018
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JDI
    PMA / PMN Number
    PK053536
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT(S): FEM PRESSURIZER SEAL LGE CATALOG#: 32833401001 LOT#: 61081515; CPT PRIMARY CENTRALIZER CATALOG#: 32833305500 LOT#: 61059507; BONE SCREW SELF-TAPPING 6.5 MM DIA. 20 MM LENGTH CATALOG#: 00625006520 LOT#: 61002409; BONE SCREW SELF-TAPPING 6.5 MM DIA. 20 MM LENGTH CATALOG#: 00625006520 LOT#: 61063098; MODULAR CUP 10 DEGREE LINER LONGEVITY 50/52/54X28 CATALOG#: 00631005028 LOT#: 60974509; TRILOGY ACET SHELL 54MM OD MULTI HA CATALOG#: 65620005420 LOT#: 60937309; CPT MOD HD ST/ST 28MMD LNG NCK CATALOG#: 00801100328 LOT#: 61005426; JRI CEMENT PLUG CATALOG#: 13-00-04 LOT#: 042284. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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 IS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY 7 YEARS POST HIP ARTHROPLASTY, DUE TO A LEFT HIP FEMORAL STEM FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569536 CPT PETITE FEMORAL COMPONENT HIP PROSTHESIS JDI ZIMMER MANUFACTURING B.V. 60338285

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R