BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR PINNACLE TOTAL HIP POROUS LT HIP

    MDR report key: 1933948 · Received December 16, 2010

    Report

    Report Number
    MW5018639
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    June 9, 2010
    Report Date
    December 16, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS INC
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    I HAD LT TOTAL HIP REPLACEMENT (B)(6) 2010. I RECEIVED THE DEPUY ASR TOTAL HIP PINNACLE ACETABULAR CUP SZ MM50, ALTRX 10 DEGREE 32 ARTICUL/EZE, AML 6' SMALL STATURE. PRIOR TO SURGERY, I HAD GROIN AND THIGH PAIN, THIS PAIN HAS INCREASED SINCE SURGERY, WITH WALKING AND WEIGHT BEARING. I AM UNABLE TO GO UP AND DOWN STAIRS, TURNING IN BED HURTS. THE PAIN IS IN THE LEFT GROIN AND GOES INTO MY LEFT THIGH AND THE LATERAL PART OF MY LEFT LEG. MY LEG IS WEAK AND EVEN WITH 3 ROUNDS OF PT STILL HAVE NO STRENGTH AND SEVERE PAIN. THE PAIN IN GROIN IS WORST WHEN LIFT LEFT LEG 45, 60 AND 90 DEGREE, IT FEELS LIKE A CLICK/CATCH AND THE PAIN IS WORST AT THOSE POINTS. I AM A REGISTERED NURSE AND HAVE TAKEN CARE OF PTS WITH HIP REPLACEMENTS, THIS IS NOT NORMAL RECOVERY. SOMETHING IS WRONG WITH THIS DEVICE. DATES OF USE: (B)(6) 2003 - (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: LT HIP DEGENERATION. PT (B)(6) 2010 XRAY LT HIP (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR PINNACLE TOTAL HIP POROUS LT HIP ASR PINNACLE TOTAL HIP FEMORAL HEAD 32 MM LPH DEPUY ORTHOPAEDICS INC 1365-21-00 2906818
    2 DEPUY ASR PINNACLE TOTAL HIP POROUS LT HIP PINNACLE SECTOR II ACETABULAR CUP SZ MM 50 LPH DEPUY ORTHOPAEDICS INC EH6HS1000
    3 DEPUY ASR PINNACLE TOTAL HIP POROUS LT HIP DEPUY PINNACLE CANCELLOUS BONE SCREW LPH DEPUY ORTHOPAEDICS INC 1217-20-500 414887
    4 DEPUY ASR PINNACLE TOTAL HIP POROUS LT HIP DEPUY AML LPH DEPUY ORTHOPAEDICS INC 1554-01-121 ET3AK1000

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| R