BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MODULAR HEAD SZ 46MM

    MDR report key: 4191136 · Received October 21, 2014

    Report

    Report Number
    0001825034-2014-08186
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    April 10, 2010
    Report Date
    September 25, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    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 RECORD SHOWS 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 1 STATES, ¿MATERIAL SENSITIVITY REACTIONS,¿ NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ NUMBER 13 STATES, "PROBLEMS OF THE KNEE OR ANKLE OF THE AFFECTED LIMB OR CONTRALATERAL LIMB AGGRAVATED BY LEG LENGTH DISCREPANCY, TOO MUCH FEMORAL MEDIALIZATION OR MUSCLE DEFICIENCIES." NUMBER 15 STATES, ¿ELEVATED METAL ION LEVELS HAVE BEEN REPORTED.¿ 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

    PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. IT IS ALLEGED THAT THE ACETABULAR REAMER BROKE DURING THIS PROCEDURE; HOWEVER, NO PIECES WERE RETAINED IN THE PATIENT. LEGAL COUNSEL FURTHER REPORTS PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2010 DUE TO PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, LACK OF MOBILITY, AND ELEVATED METAL ION LEVELS. PATIENT OPERATIVE REPORT NOTES THE PATIENT WAS REVISED DUE TO LEG LENGTH DISCREPANCY. REVIEW OF INVOICE HISTORY INDICATES THE MODULAR HEAD, TAPER ADAPTER, AND STEM 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
    669204 M2A-MAGNUM MODULAR HEAD SZ 46MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 414560

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R