BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM +10 CERAMION FEMORAL HEAD

    MDR report key: 8788861 · Received July 15, 2019

    Report

    Report Number
    0001825034-2019-02947
    Event Type
    Injury
    Date Received
    July 15, 2019
    Date of Event
    July 8, 2019
    Report Date
    February 27, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). IMPLANT DATE: APPROXIMATELY 20 YEARS AGO. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. RADIOGRAPHS IDENTIFIED THE FOLLOWING: IN BOTH AP PROJECTIONS, THE FEMORAL HEAD COMPONENT PROJECTS OVER THE SUPERIOR MARGIN OF THE ACETABULAR CUP. THIS IS CONSISTENT WITH THE REPORTED PENETRATION OF THE FEMORAL HEAD THROUGH THE LINER AND CUP. 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 · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDRS WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034 - 2019 - 02945, 0001825034 - 2019 - 02946. CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: 240052107, LOT NUMBER: 032338, ITEM NAME: INTEGRITY OSTEOCAP SHELL 52MM; ITEM NUMBER: 285254110, LOT NUMBER: 156730, ITEM NAME: INTEGRITY LINER 52-54OD 10 DEG; ITEM NUMBER: 242810106, LOT NUMBER: 030090, ITEM NAME: 28MM +10 CERAMION FEMORAL HEAD. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS REVISED TO ADDRESS LEFT HIP ACETABULAR LINER AND CUP IMPLANT FRACTURE. THE FEMORAL HEAD WORE THROUGH BOTH THE ACETABULAR LINER AND CUP AND MIGRATED INTO THE PATIENT'S PELVIS CAUSING BONE DAMAGE. THE PATIENT WAS IMPLANTED CIRCA 20 YEARS AGO. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THE TIME OF THIS REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583753 28MM +10 CERAMION FEMORAL HEAD PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 030090

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R