BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPER SECUR-FIT 127 DEGREE SIZE 8

    MDR report key: 9109430 · Received September 24, 2019

    Report

    Report Number
    0002249697-2019-03314
    Event Type
    Injury
    Date Received
    September 24, 2019
    Date of Event
    August 27, 2019
    Report Date
    November 12, 2019
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    UDI-DI
    07613327101768
    PMA / PMN Number
    K121308
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING ALTR INVOLVING A SECURFIT STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION WAS PERFORMED AS PART OF THE MATERIAL EVALUATION AND INDICATED THE FOLLOWING COMMENTS: DAMAGE CONSISTENT WITH THE IMPLANTATION/EXPLANTATION PROCESS WAS OBSERVED ON THE STEM. BIOLOGICAL MATERIAL WAS ALSO OBSERVED ON THE COATED REGION OF THE STEM. EDS ON THE DEBRIS COLLECTED FORM THE STEM WAS CONSISTENT WITH AN OXIDE, A CORROSION PRODUCT, AND BIOLOGICAL MATERIAL. BASED ON THE GIVEN INFORMATION, NO IDENTIFIABLE MATERIALS OR MANUFACTURING DISCREPANCIES WERE OBSERVED ON THE SURFACES EXAMINED. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO MEDICAL RECORDS WERE RETURNED FOR REVIEW. -PRODUCT HISTORY REVIEW: A REVIEW OF THE DEVICE MANUFACTURING RECORDS INDICATE THAT ALL DEVICES ACCEPTED INTO FINAL STOCK WERE FREE FROM DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE WERE NO OTHER EVENTS FOR THE LOT PROVIDED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS PATHOLOGY REPORTS, PRE- AND POST-OPERATIVE X-RAYS AND THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    2009.SEP.16: RESURFACING HEAD(181142/MMT) AND METAL ON METAL CUP 48MM CUP FOR 42MM HEAD( 172485/ MMT) WAS IMPLANTED. 2010.FEB.15: THE FEMORAL NECK FRACTURE WAS OCCURRED AND THA WAS DONE WITH SSF STEM AND MODULAR HEAD V40 TAPER 42MM -4MM NECK LENGTH (179-242/MMT). 2019.8.29: REVISION SURGERY OF ALL DEVICES WERE DONE BECAUSE THE LOOSENING AND ARMD WAS OCCURRED. UPDATE: "CUP WAS LOOSE." RIGHT SIDE.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE EVENT INVOLVES A DEVICE THAT IS NOT CLEARED FOR SALE IN THE U.S., BUT SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S.

    Description of Event or Problem · 1

    ON (B)(6) 2009: RESURFACING HEAD (181142/MMT) AND METAL ON METAL CUP 48MM CUP FOR 42MM HEAD (172485/ MMT) WAS IMPLANTED. ON (B)(6) 2010: THE FEMORAL NECK FRACTURE WAS OCCURRED AND THA WAS DONE WITH SSF STEM AND MODULAR HEAD V40 TAPER 42MM -4MM NECK LENGTH (179-242/MMT). ON (B)(6) 2019: REVISION SURGERY OF ALL DEVICES WERE DONE BECAUSE THE LOOSENING AND ARMD WAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907353 SUPER SECUR-FIT 127 DEGREE SIZE 8 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 30570601 07613327101768

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R