BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY PINNACLE METAL LINER, NEUTRAL 36 MM X 52 MM

    MDR report key: 3248808 · Received July 22, 2013

    Report

    Report Number
    MW5031008
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    February 16, 2009
    Manufacturer
    DEPUY ORTHOPAEDICS, INC
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2009, I UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY. I RECEIVED A DEPUY PINNACLE SECTOR II ACETABULAR CUP SIZE 52 MM, PINNACLE METAL INSERT, NEUTRAL 36 MM X 52 MM, A SUMMIT TAPERED HIP STEM SIZE 7 HIGH OFFSET, AND AN ARTICUL/EZE METAL ON METAL FEMORAL HEAD, +8.5 NECK, 36 MM. ON (B)(6) 2009, I UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY. I RECEIVED A DEPUY PINNACLE SECTOR II ACETABULAR CUP SIZE 52 MM, PINNACLE METAL INSERT, NEUTRAL 36 MM X 52 MM, A SUMMIT TAPERED HIP STEM SIZE 7 HIGH OFFSET, AND AN ARTICUL/EZE METAL ON METAL FEMORAL HEAD, +8.5 NECK, 36 MM. ON (B)(6) 2009, I RETURNED TO THE HOSP WITH A HIP DISLOCATION AND FRACTURE. I UNDERWENT A PARTIAL REVISION OF MY LEFT WHEREIN I RECEIVED AN ARTICUL/EZE METAL ON METAL FEMORAL HEAD SIZE 36 MM - 2 AND SUMMIT TAPERED HIP STEM, SIZE 8 HIGH OFFSET. THE STEM SIZE WAS INCREASED AND THE METAL ON METAL LINER WAS LEFT IN PLACE. SOON AFTER THESE SURGERIES, I BEGAN EXPERIENCING SEVERE PAIN AND DISCOMFORT. ON (B)(6) 2009, I WAS ADMITTED TO THE HOSP WITH SEPTIC SHOCK AND INFECTED MATERIAL COMING FROM MY LEFT HIP WOUND. I UNDERWENT DEBRIDEMENT AND IRRIGATION OF MY INFECTED LEFT HIP AND AGAIN ON (B)(6) 2009. SINCE THE IMPLANTATION OF THE PINNACLE DEVICES, I EXPERIENCE SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN MY RIGHT THIGH AND RIGHT HIP AREA AND LEFT THIGH AND LEFT HIP AREA. I ALSO FEEL EXTREME DISCOMFORT WHEN SITTING, WALKING, OR STANDING FOR PERIODS OF TIME. REASON FOR USE: AVASCULAR NECROSIS, RIGHT HIP. AVASCULAR NECROSIS, LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341547 DEPUY PINNACLE METAL LINER, NEUTRAL 36 MM X 52 MM METAL-ON-METAL HIP IMPLANT KWA DEPUY ORTHOPAEDICS, INC 121887352 2719711
    341548 DEPUY SUMMIT TAPERED HIP STEM SIZE 7, HIGH OFFSET METAL-ON-METAL HIP IMPLANT JDI DEPUY ORTHOPAEDICS, INC 1570-11-135 DC3F21000
    341549 DEPUY ARTICUL/EZE METAL ON METAL FEMORAL HEAD, 36 MM +5 METAL-ON-METAL HIP IMPLANT JDI DEPUY ORTHOPAEDICS, INC 1365-52-000 2909929
    341550 DEPUY PINNACLE SECTOR II ACETABULAR CUP, SIZE 52 METAL-ON-METAL HIP IMPLANT KWA DEPUY ORTHOPAEDICS, INC 1217-22-052 DS7GX1000
    341551 DEPUY PINNACLE METAL INSERT, NEUTRAL 36 MM X 52 MM METAL-ON-METAL HIP IMPLANT KWA DEPUY ORTHOPAEDICS, INC 1218-87-352 2747883
    341552 DEPUY ARTICUL/EZE METAL ON METAL FEMORAL HEAD, 36 MM -2 METAL-ON-METAL HIP IMPLANT JDI DEPUY ORTHOPAEDICS, INC 1365-50-000 2753075
    341553 DEPUY SUMMIT TAPERED HIP STEM, SIZE 8 HIGH OFFSET METAL-ON-METAL HIP IMPLANT JDI DEPUY ORTHOPAEDICS, INC 1570-11-150 BB3D41000
    341717 DEPUY PINNACLE SECTOR II ACETABULAR CUP, SIZE 52 MM METAL-ON-METAL HIP IMPLANT KWA DEPUY ORTHOPAEDICS, INC 1217-22-052 DC1EG1000
    341718 DEPUY ARTICUL/EZE METAL ON METAL FEMORAL HEAD, 36 MM METAL-ON-METAL HIP IMPLANT JDI DEPUY ORTHOPAEDICS, INC 1365-53-500 2732761
    341719 DEPUY SUMMIT TAPERED HIP STEM SIZE 7, HIGH OFFSET METAL-ON-METAL HIP IMPLANT JDI DEPUY ORTHOPAEDICS, INC 1570-11-135 DK9CT1

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R| S