BEUDAMED
    FDA Adverse Event Injury Summary report: N

    25MM MOD REV HIP BDY/BLT +20MMCOMPONENT LEVEL 9006-1-225

    MDR report key: 3984181 · Received August 6, 2014

    Report

    Report Number
    0002249697-2014-03014
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 16, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K040734
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION BECAUSE THE SURGEON KEPT IT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) INCHES IN HEIGHT. AN EVENT REGARDING OFF-LABEL USE INVOLVING A 25MM MOD REV HIP BDY/BLT +20MM COMPONENT LEVEL 9006-1-225 WAS REPORTED. CONCLUSION: THE REPORTED EVENT INVOLVES DISLOCATION AND SUBSEQUENTLY REVISION. A (B)(6) MEDICAL CUP WAS IMPLANTED WITH A RESTORATION MODULAR STEM. THIS INDICATED OFF-LABEL USE AND A POSSIBLE CONTRIBUTING FACTOR TO THE DISLOCATION. BASED ON THE PROVIDED INFORMATION, THE PRODUCT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE MONTHS AGO, REVISION SURGERY WAS PERFORMED IN WHICH A WRIGHT MEDICAL STEM WAS REMOVED, BUT THE CUP WAS RETAINED. A RESTORATION MODULAR WAS UTILIZED. EVIDENTLY, PATIENT DISLOCATED AND THE SURGEON DECIDED TO COME BACK TO DECREASE THE COMBINED ANTEVERSION OF THE CUP AND CONE BODY. THE WRIGHT ACETABULUM WAS REPLACED USING A TRITANIUM REVISION SHELL AND WAS EXPLANTED IN A POSITION OF LESS ANTERVERSION. A NEW CONE BODY WAS ALSO IMPLANTED WITH LESS ANTERVERSION, RESULTING IN A STABLE CONTRAST, ESPECIALLY ANTERIORLY. NOTHING WAS LOOSE OR BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE MONTHS AGO, REVISION SURGERY WAS PERFORMED IN WHICH A (B)(6) MEDICAL STEM WAS REMOVED, BUT THE CUP WAS RETAINED. A RESTORATION MODULAR WAS UTILIZED. EVIDENTLY, PATIENT DISLOCATED AND THE SURGEON DECIDED TO COME BACK TO DECREASE THE COMBINED ANTEVERSION OF THE CUP AND CONE BODY. THE WRIGHT ACETABULUM WAS REPLACED USING A TRITANIUM REVISION SHELL AND WAS EXPLANTED IN A POSITION OF LESS ANTEVERSION. A NEW CONE BODY WAS ALSO IMPLANTED WITH LESS ANTEVERSION, RESULTING IN A STABLE CONTRAST, ESPECIALLY ANTERIORLY. NOTHING WAS LOOSE OR BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461485 25MM MOD REV HIP BDY/BLT +20MMCOMPONENT LEVEL 9006-1-225 IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH 43444601

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R