BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP CEMENT FMRL HD RESUR 52M

    MDR report key: 3970551 · Received July 31, 2014

    Report

    Report Number
    0001825034-2014-06644
    Event Type
    Injury
    Date Received
    July 31, 2014
    Report Date
    July 7, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KXA
    PMA / PMN Number
    PK021799
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. 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 OF THE FEMORAL NECK AND/OR POSTOPERATIVE PAIN." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-06643 & 06644).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PAIN, LACK OF MOBILITY, DAMAGE TO BONE/TISSUE, METAL POISONING, METALLOSIS AND ELEVATED METAL ION LEVELS. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE. A REVIEW OF THE INVOICE HISTORY INDICATES PATIENT UNDERWENT A FEMORAL RESURFACING PROCEDURE ON (B)(6) 2009. 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
    448548 RECAP CEMENT FMRL HD RESUR 52M PROSTHESIS, HIP KXA BIOMET ORTHOPEDICS N/A 162780

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R