BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SIZE 3 STRYKER STEM

    MDR report key: 14403163 · Received May 14, 2022

    Report

    Report Number
    0002249697-2022-00706
    Event Type
    Injury
    Date Received
    May 14, 2022
    Date of Event
    October 27, 2019
    Report Date
    May 13, 2022
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: MITCH 54 ACETABULAR COMPONENT OEM; CAT # UNK SHC; LOT # UNKNOWN. MITCH 48 +0 HEAD OEM; CAT # UNK SHC; LOT # UNKNOWN. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. NOT AVAILABLE.

    Description of Event or Problem · 0

    ON (B)(6) 2008, A STRYKER PROSTHESIS, METAL-METAL CUP, STEM 3, ACETABULUM 54, HEAD 48 + 0, HEAD MITCH WAS IMPLANTED IN THE PATIENT'S RIGHT HIP. AFTER SOME TIME FROM THIS IMPLANT, THE PATIENT BEGAN TO FEEL COXALGIA AND VARIOUS DISABLING DISORDERS. ONLY ON (B)(6) 2019 DID THE PATIENT UNDERGO A REVISION OF THE PROSTHETIC IMPLANT. THE FOLLOWING IS NOTED ON THE MEDICAL RECORD OF THE OPERATION: "ABUNDANT GREYISH LIQUID LEAKS. PART OF THE LIQUID IS WITHDRAWN FOR EVALUATION OF IONEMIA AND ANTIBIOGRAM. IT REACHES THE LEVEL OF THE PROSTHETIC PLANE AND THE COMPONENT OF THE FEMORAL HEAD IS REMOVED. THE PROSTHETIC COLLAR APPEARS IN GOOD CONDITION. A HYPERPLASTIC / INFLAMMATORY REACTION (PSEUDOTUMOR TYPE) IS FOUND IN THE INFERO-ANTERIOR AND INFERO-POSTERIOR REGION WITH RESPECT TO THE HIP JOINT. THERE IS ALSO AN OSTEOLYTIC LESION IN THE TROCHANTERIC REGION WHERE CURETTAGE AND WADING WITH HETEROLOGOUS BONE CHIPS ARE PERFORMED. EXTENSIVE REMOVAL OF THE PSEUDOTUMOR DESCRIBED ABOVE AND DISPATCH OF THE MATERIAL." THE HISTOLOGICAL EXAMINATION OF THE EXPLANTED MATERIAL RESULTED SIGNIFICANT FOR THE PRESENCE OF CHRONIC INFLAMMATION WITH DEPOSITION OF EXOGENOUS PIGMENTED MATERIAL OF THE STROMA AND BONE TISSUE. THE PATIENT HAS BEEN DEVELOPING THE ARMD ¿ ADVERSE REACTION TO METAL DEBRISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1395698 UNKNOWN_SIZE 3 STRYKER STEM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H