BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECUR-FIT HA PSL CUP/CLUSTR SHELL 52MM

    MDR report key: 2964572 · Received February 15, 2013

    Report

    Report Number
    0002249697-2013-00706
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDK
    PMA / PMN Number
    K965056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. PATIENT X-RAYS AND PHOTOGRAPHS OF THE EXPLANTED COMPONENTS WERE PROVIDED FOR REVIEW BY A CONSULTING CLINICIAN WHO INDICATED THAT THERE IS NO EVIDENCE THAT FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING, OR MATERIALS WERE RESPONSIBLE FOR THIS CLINICAL SITUATION. THE EXACT ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED DUE TO MINIMAL INFORMATION PROVIDED. ADDITIONAL PATIENT RECORDS SUCH AS PATIENT DEMOGRAPHICS, OPERATIVE REPORTS, AND/OR PAST CLINICAL HISTORY WOULD BE NECESSARY IN FURTHER EVALUATING THIS EVENT AND DETERMINING A ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    THE UNKNOWN LINER WAS ALSO LISTED IN THIS REPORT. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S DISLOCATION. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE HOSPITAL AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON WAS DOING A RIGHT HIP REVISION - FOR DISLOCATION. SURGEON SAID PATIENT WAS WALKING ON DISLOCATED HIP FOR APPROXIMATELY 3 MONTHS (12 WEEKS) AND WORE OUT A BIG CHUNK OF THE CUP AS A RESULT OF WALKING ON THE DISLOCATION FOR SUCH A LONG PERIOD OF TIME. CUP AND LINER WERE REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT, HEAD WAS REPLACED WITH STRYKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON WAS DOING A RIGHT HIP REVISION - FOR DISLOCATION. SURGEON SAID PATIENT WAS WALKING ON DISLOCATED HIP FOR APPROXIMATELY 3 MONTHS (12 WEEKS) AND WORE OUT A BIG CHUNK OF THE CUP AS A RESULT OF WALKING ON THE DISLOCATION FOR SUCH A LONG PERIOD OF TIME. CUP AND LINER WERE REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT, HEAD WAS REPLACED WITH STRYKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68669 SECUR-FIT HA PSL CUP/CLUSTR SHELL 52MM IMPLANT JDK STRYKER ORTHOPAEDICS-MAHWAH RH3093

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention