BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECUR-FIT SHELL FOR CERAMIC SIZE 46 JAPAN

    MDR report key: 3941600 · Received July 17, 2014

    Report

    Report Number
    0002249697-2014-02785
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 2, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING IMPLANT MIGRATION INVOLVING A SECURFIT SHELL WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: INSPECTION OF THE DEVICE INDICATES THERE IS EXPLANATION DAMAGE ON THE RIM OF THE SHELL. NO MATERIALS OR MANUFACTURING DEFECTS WERE OBSERVED ON THE DEVICE. MEDICAL RECORDS RECEIVED AND EVALUATION: REVIEW OF RECORDS INDICATE THE SHELL WAS NOT ADEQUATELY FIXED, PUSHING THE INSERT OUT OF THE SHELL CAUSING MIGRATION. A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED: ¿THE FAILURE SCENARIO HAS BEEN DISCUSSED STARTING WITH INADEQUATE CUP SHELL FIXATION WITH SOLID ADDITIONAL SCREW FIXATION OF THE SHELL ULTIMATELY PUSHING THE INSERT OUT OF THE SHELL WHILE THE CUP MIGRATED IN CENTRAL DIRECTION AND THE SCREW HEADS REMAINED SOLID IN THE BONE. DURING FURTHER LOOSENING, THE CUP TILTED INTO VERTICAL POSITION WHEN SQUEAKING STARTED TO DEVELOP THROUGH EDGE LOADING OF THE DEVICE. THE SQUEAKING IS THUS A SECONDARY PROBLEM DEVELOPING AFTER THE CUP BECAME LOOSE. AS SUCH IT IS A PROCEDURE-RELATED PHENOMENON. ALSO THE CUP LOOSENING IS SUSPECTED TO BE CAUSED BY PROCEDURE-RELATED FACTORS BUT THERE IS NOT ENOUGH X-RAY INFORMATION AVAILABLE TO PROVE SUCH WITH CERTAINTY. NO EVIDENCE FOR DEVICE-RELATED FACTORS WHILE ALSO PATIENT-RELATED FACTORS ARE NOT OF PRINCIPAL RELEVANCE IN THIS CASE.¿ DEVICE HISTORY REVIEW: THE REPORTED DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT ID. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT THE CAUSE OF THE REPORTED EVENT IS PROCEDURE RELATED. MEDICAL REVIEW INDICATED THE SHELL WASN¿T FIXED ADEQUATELY, LEADING TO THE SHELL PUSHING THE INSERT OUT OF THE SHELL, LEADING TO MIGRATION. DURING FURTHER LOOSENING, THE CUP TILTED CREATING SQUEAKING. THERE IS NO INDICATION THE REPORTED EVENT IS DEVICE RELATED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT THA SURGERY WITH SSF, CUP AND CERAMIC INSERT AND CERAMIC HEAD ON (B)(6) 2007 FOR OA. AFTER OPERATION, THE CUP MIGRATED TO MEDIAL SUPERIOR AND SQUEAKING WAS OCCURRED. THE SQUEAKING WAS OCCURRED FROM (B)(6) 2013. THE REVISION OPERATION OF CUP, HEAD AND LINER WAS DONE AT (B)(6) 2014 FOR SQUEAKING AND THE CUP MIGRATION TO MEDIAL SIDE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT THA SURGERY WITH SSF, CUP AND CERAMIC INSERT AND CERAMIC HEAD ON (B)(6) 2007 FOR OA. AFTER OPERATION, THE CUP MIGRATED TO MEDIAL SUPERIOR AND SQUEAKING WAS OCCURRED. THE SQUEAKING WAS OCCURRED FROM (B)(6) 2013. THE REVISION OPERATION OF CUP, HEAD AND LINER WAS DONE AT (B)(6) 2014 FOR SQUEAKING AND THE CUP MIGRATION TO MEDIAL SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419073 SECUR-FIT SHELL FOR CERAMIC SIZE 46 JAPAN IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 21339101

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R