BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR FMRL 7.5X135

    MDR report key: 2992617 · Received March 7, 2013

    Report

    Report Number
    0001825034-2013-00529
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    June 23, 2009
    Report Date
    February 11, 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
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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 4 STATES: "LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY." NUMBER 14 STATES: "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR PAIN." THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 0001825034-2013-00526 / 00529). THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION RECEIVED IN MEDICAL RECORDS, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THE STEM WAS NOT REMOVED IN THE REVISION PROCEDURE ON (B)(6) 2008. THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 0001825034-2013-00526 / 00529).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES PATIENT UNDERWENT M2A HIP ARTHROPLASTY ON (B)(6) 2007. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2009. PATIENT ALLEGES PAIN AND LOOSENING. ADDITIONAL INFORMATION PROVIDED IN REVISION INVOICE CONFIRMS REVISION DATE. 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.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTS THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND THAT A REVISION PROCEDURE WAS PERFORMED DUE TO PATIENT ALLEGATIONS OF PAIN AND LOOSENING. A REVIEW OF INVOICE HISTORY CONFIRMED THAT THE PRIMARY SURGERY TOOK PLACE ON (B)(6) 2007 AND THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2008 IN WHICH ALL COMPONENTS WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2008 WAS DUE TO ACETABULAR CUP LOOSENING, PAIN AND METALLOSIS. THE OPERATIVE NOTES CONFIRM THAT THE ACETABULAR CUP, TAPER ADAPTER AND MODULAR HEAD WERE REMOVED AND REPLACED. 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
    97822 TAPERLOC POR FMRL 7.5X135 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 408360

    Patients

    Seq Age Sex Outcome Treatment
    1 16 MO Hospitalization| R