BEUDAMED
    FDA Adverse Event Summary report: N

    PINNACLE SECTOR ACETABULAR CUP W/DUGFIX HA, 52MM 50

    MDR report key: 3020669 · Received March 18, 2013

    Report

    Report Number
    MW5029437
    Date Received
    March 18, 2013
    Date of Event
    May 14, 2008
    Report Date
    March 18, 2013
    Manufacturer
    DEPUY
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    BONE LOSS, PAIN, INFLAMMATORY REACTION, SWELLING, REVISION SURGERY, AVASCULAR NECROSIS. OFFICE CONSULTS FOR PAIN BECAUSE IMPLANT DOCTOR REFUSED TO BELIEVE IT COULD BE A PROBLEM WITH THE HIP THAT WAS CAUSING HER PAIN. PAIN MANAGEMENT, DR. (B)(6). TREATMENT OF LOWER BACK BECAUSE HIP IMPLANT DOCTOR RECUSED TO BELIEVE IT COULD BE THE HIP CAUSING HER PAIN AND PROBLEMS WALKING. CHIROPRACTIC - (B)(6). NEUROLOGICAL EXAMS BECAUSE IMPLANT DOCTOR REFUSED TO BELIEVE IT COULD BE THE HIP CAUSING HER PAIN AND PROBLEMS WALKING. DR. (B)(6). PHYSICAL THERAPY FOR RECOVER FROM IMPLANT IN 2008 AND CONTINUED PROBLEMS AFTER RECOVERY. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112089 PINNACLE SECTOR ACETABULAR CUP W/DUGFIX HA, 52MM 50 PINNACLE HP WITH MOM LINER, CUP KWA DEPUY 0F8J41000
    112090 PINNACLE ACETABULAR, PINNACLE CANCELLOUS BONE SCREW DIAM MM6-5MM LOT 25 PINNACLE HP MOMLINER, BONE SCREW HWC DEPUY 84HRX4000
    112091 PINNACLE ACETABULAR, SUMMIT TANERED HIP STEM W/DUOFIX HA, 252 STD OFFSET 130MM L PINNACLE HP WITH MOM LINER, STEM LWJ DEPUY 133PHC1000
    112092 METAL INSERT NEUTRAL 36MM D X 5MM CUP PINNACLE HP WITH MOM LINER, INSERT JDI DEPUY 24908577
    112113 ARTICUL/EZE METAL ON METAL FEMORAL HEAD PINNACLE HP WITH MOM LINER, HEAD JDI DEPUY 2557536

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R| S