BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR LAT FEMORAL 9X137

    MDR report key: 2931861 · Received January 28, 2013

    Report

    Report Number
    0001825034-2013-00158
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    May 22, 2012
    Report Date
    January 7, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 14 STATES, "POSTOPERATIVE BONE FRACTURE AND PAIN." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01305-1 / 01307-1 & 2013-00158).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND REPORTS PATIENT ALLEGATIONS OF BONE LOSS. ADDITIONAL INFORMATION PROVIDED IN OPERATIVE NOTES AND A REVIEW OF INVOICE HISTORY CONFIRMS THE HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2008. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2012 DUE TO BONE LOSS, PAIN, PERIPROSTHETIC FRACTURE, AND CUP LOOSENING. DURING THE PROCEDURE, THE HEAD COULD NOT BE DISENGAGED AND A WELL FIXED STEM WAS DIFFICULT TO REMOVE RESULTING IN FEMORAL FRACTURE. IT WAS ALSO NOTED DURING PROCEDURE THERE WAS GRAY FLUID AND TISSUE. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37805 TAPERLOC POR LAT FEMORAL 9X137 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 585060

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R