BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD OPTION HEAD 36MM

    MDR report key: 3945509 · Received July 21, 2014

    Report

    Report Number
    0001825034-2014-06273
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    March 12, 2014
    Report Date
    July 11, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK082996
    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "MATERIAL SENSITIVITY REACTIONS.¿ AND "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." AND "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." AND "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES." AND ¿DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING.¿ THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-02868/ -02869/ -02870 AND -06273).

    Description of Event or Problem · 1

    LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007 AND A REVISION PROCEDURE ON (B)(6) 2014, DUE TO PATIENT ALLEGATIONS OF PAIN, DYSFUNCTION, SWELLING, INFLAMMATION, AND DAMAGE TO SURROUNDING BONE AND TISSUE, LOSS OF RANGE OF MOTION, LACK OF MOBILITY, AND ELEVATED METAL ION LEVELS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT¿S OPERATIVE (OP) NOTES DATED (B)(6) 2014 REPORTS, PATIENT WAS REVISED DUE TO PAIN AND METAL-TO-METAL HYPERSENSITIVITY. REVISION OP REPORT NOTES THE PRESENCE OF GRAYISH REACTIVE TYPE TISSUE WITHIN THE PSEUDOCAPSULE AROUND THE COMPONENT AND CLEAR YELLOWISH FLUID WITH SLIGHT BLOODY TINGE. ADDITIONALLY, OP REPORT NOTES THE CUP SHOWED NO BONY INGROWTH. THE CUP, TAPER INSERT, AND MODULAR HEAD WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN PATIENT¿S OP NOTES DATED (B)(6) 2014 REPORTS: PATIENT WAS REVISED DUE TO AN UNSTABLE LEFT HIP. REVISION OP REPORT NOTES A DISRUPTION OF POSTERIOR SOFT TISSUES AND BLOODY FLUID BUT NO SIGN OF INFECTION. THE MODULAR HEAD AND LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424620 CER BIOLOXD OPTION HEAD 36MM PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 259410

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R