BEUDAMED
    FDA Adverse Event Summary report: N

    BIOLOX AND DELTA ARTICUL/EZE FEMORAL HEAD 36MM

    MDR report key: 3020666 · Received March 18, 2013

    Report

    Report Number
    MW5029436
    Date Received
    March 18, 2013
    Date of Event
    January 21, 2009
    Report Date
    March 18, 2013
    Manufacturer
    DEPUY
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    CONSTANT PAIN: 2009, PROBLEMS WALKING: 2009, SQUEAKING NOISE: 2009, CATCHING: 2009, POPPING: 2009, (B)(6) 2009: 2010, HIP FAILED AND I FELL: 2011. I HAVE CONTINUED PAIN. I HAVE FALLEN 3 TIMES. I HAVE CONTINUOUS PROBLEMS WALKING. THE FIRST IMPLANT MADE A SQUEAKING NOISE, CATCHING AND POPPING FROM THE BEGINNING. WHEN THE HIP FAILED, THE HIP MADE A NOISE AND CAUSED ME TO FALL TO THE GROUND. I COULD NO LONGER STAND ON IT. THE REVISION WAS MADE AND I HAVE BEEN ABLE TO WALK, BUT NOT FOR LONG DISTANCES AND IT STILL "POPS" ON OCCASION. CONSULTS WITH OTHER DOCTORS FOR LENGTH DISCREPANCY 2009. ALSO FOR PAIN IN 2010, REVISION 2011. CONSULT WITH PODIATRIST FOR PROSTHETICS 2009 TO 2010. PHYSICAL THERAPY (B)(6) 2009 TO (B)(6) 2009 AND (B)(6) 2010 TO (B)(6) 2010. PAIN MEDICATIONS 2009 TO 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112080 BIOLOX AND DELTA ARTICUL/EZE FEMORAL HEAD 36MM PINNACLE HIP IMPLANT WITH MOM LINER, HEAD JDI DEPUY 2808916
    112081 SUMMIT BASIC CEMENTED SZ 5 PINNACLE HIP IMPLANT WITH MOM LINER, STEM LWJ DEPUY C4CA41000
    112082 CEMENTRALIZEN STEM CENTRALIZER 13MM DIA PINNACLE HIP IMPLANT WITH MOM LINER, STEM CENTRALIZER KWY DEPUY C25JA1000
    112083 APEX HOLE ELIMINATOR - PS PINNACLE HIP IMPLANT WITH MOM LINER, HOLE ELIMINATOR JDI DEPUY C83MB1000
    112084 PINNACLE CANNCELOUS BONE SCREW SZ 65 PINNACLE HIP IMPLANT WITH MOM LINER, BONE SCREW HWC DEPUY CC6LB4000
    112085 PINNACLE CANNCELOUS BONE SCREW SZ 65 PINNACLE HIP IMPLANT WITH MOM LINER, BONE SCREW HWC DEPUY B4KAJ4000
    112086 PINNACLE CANNCELOUS BONE SCREW SZ 6.5 PINNACLE HIP IMPLATN WITH MOM LINER, BONE SCREW HWC DEPUY B87BH4000
    112087 PINNACLE METAL INSERT 36X52 PINNACLE HIP IMPLATN WITH MOM LINER, INSERT KWA DEPUY 2772273
    112088 PINNACLE SECTOR II ACETABULAR CUP PINNACLE HIP IMPLANT WITH MOM LINER, ACETABULAR CUP JDI DEPUY B4KAJ4000

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R| S