BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALUMINA V40-FEMORAL HEAD 36MM, -5MM NK

    MDR report key: 3050759 · Received April 10, 2013

    Report

    Report Number
    0002249697-2013-01234
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K023901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING ALLERGY/REACTION INVOLVING AN UNIDENTIFIED CERAMIC HEAD WAS REPORTED. THE EVENT WAS CONFIRMED. THE SUBJECT DEVICE WAS REPORTED WITH A VALID CATALOGUE NUMBER. HOWEVER, THE ACTUAL MARKINGS ON THE DEVICE COULD NOT BE IDENTIFIED BY STRYKER AND ITS RELEVANT SUPPLIERS. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    REVISION OF TRIDENT CERAMIC LINER AFTER TEN YEARS IMPLANTATION DUE TO THE FOLLOWING: AT NINE YEARS POST PRIMARY HIP SURGERY (ABG STEM, 36 MM CERAMIC HEAD, 60MM TRIDENT CUP, #G CERAMIC LINER) THE PATIENT PRESENTED WITH A GOLF BALL SIZED LUMP IN THE HIP AREA THAT WAS DRAINING THROUGH AN EXIT SINUS AT THE DISTAL END OF THE SURGERY INCISION SCAR. THE FLUID EXITING THE SINUS WAS MILKY IN COLOUR AND VISCOSITY. THERE WERE NO MARKERS OF INFECTION IN BLOOD TESTS AND BEFORE ANY STEPS TO REMOVE THE MASS IT REDUCED IN SIZE, NO SURGERY TO REMOVE IT WAS PERFORMED. ONE YEAR LATER (10 YEARS POST PRIMARY IMPLANTATION) THE PATIENT PRESENTED AGAIN WITH THE MASS GROWING AND DRAINING AS IT HAD THE PRIOR YEAR. THE SURGEON DECIDED TO OPERATE WITH THE INTENTION OF INVESTIGATING THE NATURE OF THE POSSIBLY REVISING THE HEAD AND LINER COMPONENTS OF THE IMPLANT DEPENDING ON WHAT WAS FOUND. PRIOR TO SURGERY ON THE EXIT SINUS OF THE MASS WAS EXAMINED. AFTER OPENING THE EXISTING SCAR, A CYST WAS FOUND BENEATH THE SKIN WITH A LONG TRACT ENTERING THE JOINT CAPSULE. THIS WAS REMOVED AND THE CAPSULE OPENED AND THE JOINT DISLOCATED. THE CERAMIC HEAD WAS REMOVED AND A WHITISH THICK BUTTER LIKE SUBSTANCE WAS FOUND AROUND THE BASE OF THE TRUNION. THE INSIDE OF THE HEAD HAD A BLACK STRIPE THAT THE SURGEON SAID WAS FROM TRUNION HEAD MOVEMENT CAUSING WEAR OF THE TRUNION. THE CERAMIC LINER WAS REMOVED AND BEHIND THE LINER AND AROUND THE ACETABULUM THE SAME BUTTERY SUBSTANCE WAS FOUND. THE INSIDE OF THE IMPLANTED SHELL ALSO HAD THE SAME SUBSTANCE ON ITS SURFACE. THE EXPLANTS WERE REVISED TO AN X3 POLYETHYLENE LINER AND LFIT 36MM -5 HEAD.

    Description of Event or Problem · 1

    REVISION OF TRIDENT CERAMIC LINER AFTER TEN YEARS IMPLANTATION DUE TO THE FOLLOWING: AT NINE YEARS POST PRIMARY HIP SURGERY (ABG STEM, 36 MM CERAMIC HEAD, 60MM TRIDENT CUP, #G CERAMIC LINER) THE PATIENT PRESENTED WITH A GOLF BALL SIZED LUMP IN THE HIP AREA THAT WAS DRAINING THROUGH AN EXIT SINUS AT THE DISTAL END OF THE SURGERY INCISION SCAR. THE FLUID EXITING THE SINUS WAS MILKY IN COLOUR AND VISCOSITY. THERE WERE NO MARKERS OF INFECTION IN BLOOD TESTS AND BEFORE ANY STEPS TO REMOVE THE MASS IT REDUCED IN SIZE, NO SURGERY TO REMOVE IT WAS PERFORMED. ONE YEAR LATER (10 YEARS POST PRIMARY IMPLANTATION) THE PATIENT PRESENTED AGAIN WITH THE MASS GROWING AND DRAINING AS IT HAD THE PRIOR YEAR. THE SURGEON DECIDED TO OPERATE WITH THE INTENTION OF INVESTIGATING THE NATURE OF THE POSSIBLY REVISING THE HEAD AND LINER COMPONENTS OF THE IMPLANT DEPENDING ON WHAT WAS FOUND. PRIOR TO SURGERY ON THE EXIT SINUS OF THE MASS WAS EXAMINED. AFTER OPENING THE EXISTING SCAR, A CYST WAS FOUND BENEATH THE SKIN WITH A LONG TRACT ENTERING THE JOINT CAPSULE. THIS WAS REMOVED AND THE CAPSULE OPENED AND THE JOINT DISLOCATED. THE CERAMIC HEAD WAS REMOVED AND A WHITISH THICK BUTTER LIKE SUBSTANCE WAS FOUND AROUND THE BASE OF THE TRUNNION. THE INSIDE OF THE HEAD HAD A BLACK STRIPE THAT THE SURGEON SAID WAS FROM TRUNNION HEAD MOVEMENT CAUSING WEAR OF THE TRUNNION. THE CERAMIC LINER WAS REMOVED AND BEHIND THE LINER AND AROUND THE ACETABULUM THE SAME BUTTERY SUBSTANCE WAS FOUND. THE INSIDE OF THE IMPLANTED SHELL ALSO HAD THE SAME SUBSTANCE ON ITS SURFACE. THE EXPLANTS WERE REVISED TO AN X3 POLYETHYLENE LINER AND LFIT 36MM -5 HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149181 ALUMINA V40-FEMORAL HEAD 36MM, -5MM NK IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R