BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR POROUS LATERALIZED REDUCED DISTAL TAPERLOC FEMORAL

    MDR report key: 7323645 · Received March 8, 2018

    Report

    Report Number
    0001825034-2018-01742
    Event Type
    Injury
    Date Received
    March 8, 2018
    Date of Event
    February 1, 2018
    Report Date
    March 8, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: M2A 38MMX50MM CUP CAT: RD118850 LOT: 395740, M2A 38MM MOD HD -3MM NK CAT: 11-173661 LOT: 130390. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-01209, 0001825034-2018-01742, 0001825034-2018-01743. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. 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 IN REVISION OPERATIVE NOTES THAT THE PATIENT UNDERWENT A TOTAL HIP REVISION APPROXIMATELY 15 YEARS POST OP DUE TO OSTEOLYSIS, MALPOSITIONING, AND CORROSION. THE FEMORAL HEAD WAS REMOVED AND A SMALL AMOUNT OF TAPER CORROSION WAS NOTED, BUT NO STRUCTURAL DAMAGE WAS APPARENT TO THE FEMORAL STEM. THERE WAS A SMALL POCKET OF OSTEOLYSIS NOTED ABOUT THE PROXIMAL FEMUR; THE ACETABULAR SIDE WAS NOTED TO BE SIGNIFICANTLY MALPOSITIONED IN A RETROVERTED MANNER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168652 MODULAR POROUS LATERALIZED REDUCED DISTAL TAPERLOC FEMORAL HIP PROSTHESIS LPH ZIMMER BIOMET, INC. 771480

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R