BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR FMRL LAT 7.5X135

    MDR report key: 3567326 · Received January 10, 2014

    Report

    Report Number
    0001825034-2014-00244
    Event Type
    Injury
    Date Received
    January 10, 2014
    Report Date
    December 11, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK921301
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 ¿MATERIAL SENSITIVITY REACTIONS.¿ AND "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 5 OF 7 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-00238/-00239/-00241/-00242/-00244/-00246/-00247).

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2002. SINCE THE PROCEDURES, THE PATIENT ALLEGES PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, ELEVATED METAL IONS, LOSS OF RANGE OF MOTION AND METALLOSIS. THERE HAS BEEN NO REPORTED REVISION PROCEDURE. NO FURTHER INFORMATION AVAILABLE AT THIS TIME. 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
    20136 TAPERLOC POR FMRL LAT 7.5X135 PROTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 959750

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization