BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR FMRL LAT 7.5X135

    MDR report key: 3638205 · Received February 20, 2014

    Report

    Report Number
    0001825034-2014-01039
    Event Type
    Injury
    Date Received
    February 20, 2014
    Report Date
    January 22, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." AND "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." AND ¿MATERIAL SENSITIVITY REACTIONS.¿ THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 5 OF 5 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-01035/-01036/-01037/-01038/-01039).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A TOTAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2005 AND A TOTAL LEFT HIP ARTHROPLASTY ON (B)(6) 2005. LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, DYSFUNCTION, LOSS OF MOBILITY, AND LOSS OF RANGE OF MOTION. SUBSEQUENTLY, PATIENT'S RIGHT HIP WAS REVISED ON (B)(6) 2013. LEGAL DOCUMENT FURTHER ALLEGES THE PRESENCE OF METALLOSIS, TISSUE NECROSIS AND HYPERTROPHIC SYNOVIAL TISSUE DURING THE REVISION SURGERY. REVIEW OF INVOICE HISTORY INDICATES THAT THERE WAS A SECOND REVISION FOR THE RIGHT HIP PERFORMED ON (B)(6) 2013 FOR UNKNOWN REASONS. NO REVISION FOR THE LEFT HIP HAS BEEN REPORTED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107796 TAPERLOC POR FMRL LAT 7.5X135 PROTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 392340

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization