BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-TAPER LINER SZ 41/32

    MDR report key: 3852453 · Received June 5, 2014

    Report

    Report Number
    0001825034-2014-05280
    Event Type
    Injury
    Date Received
    June 5, 2014
    Report Date
    February 13, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK921181
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. 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 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." NUMBER 14 STATES, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ NUMBER 4 STATES, ¿LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR.¿ THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 4 OF 5 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-01121 / -01123 AND -05280 / -05281).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THAT THIS MEDWATCH IS BEING UPDATED TO REPORT ON THE LINER ASSOCIATED WITH THIS COMPLAINT (THE LINER IS THE ARTICULATING SURFACE) AND NOT THE CUP AS WAS PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT¿S RIGHT HIP WAS REVISED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, BONE/TISSUE DAMAGE, FLUID BUILD-UP AROUND HIP JOINT AND METALLOSIS. THE MODULAR HEAD, ACETABULAR CUP AND TAPER ADAPTER WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED FROM PATIENT OPERATIVE (OP) NOTES FOR THE RIGHT HIP REPORTS PATIENT WAS REVISED DUE TO PAIN AND LOOSENING OF THE ACETABULAR COMPONENT. ADDITIONAL INFORMATION RECEIVED ALSO REPORTS PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2002. THERE HAS BEEN NO REPORTED REVISION TO DATE FOR THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329300 M2A-TAPER LINER SZ 41/32 PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 521100

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization