BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPER SECUR-FIT 127 DEGREE SIZE 7

    MDR report key: 6247717 · Received January 12, 2017

    Report

    Report Number
    0002249697-2017-00214
    Event Type
    Injury
    Date Received
    January 12, 2017
    Date of Event
    December 24, 2016
    Report Date
    April 10, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    UDI-DI
    07613327101751
    PMA / PMN Number
    K121308
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: AN EVENT REGARDING INTRAOP FRACTURE INVOLVING A SECURFIT STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. -MEDICAL RECORDS RECEIVED AND EVALUATION: A MEDICAL REVIEW WAS NOT PERFORMED BECAUSE NO MEDICAL INFORMATION WAS PROVIDED. -DEVICE HISTORY REVIEW: REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: REVIEW INDICATED THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION, INCLUDING OPERATIVE REPORTS, X-RAYS, PROGRESS NOTES AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE OR THE PRODUCT IS RETURNED, THIS INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION

    Description of Event or Problem · 1

    FRACTURE WHEN INSERTING THE STEM FOR THA TREATMENT. ATTEMPTED TO TREAT BY D-M CABLE, BUT WOULDN'T CROSS INTO THE SINGLE SIDE TENSIONER AND COULDN'T REMOVE THE CABLE FROM THE TENSIONER. INSTEAD CABLE WAS CUT AND ANOTHER CABLE WAS USED TO COMPLETE PROCEDURE.

    Description of Event or Problem · 1

    FRACTURE WHEN INSERTING THE STEM FOR THA TREATMENT. ATTEMPTED TO TREAT BY D-M CABLE, BUT WOULDN'T CROSS INTO THE SINGLE SIDE TENSIONER AND COULDN'T REMOVE THE CABLE FROM THE TENSIONER. INSTEAD CABLE WAS CUT AND ANOTHER CABLE WAS USED TO COMPLETE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30315 SUPER SECUR-FIT 127 DEGREE SIZE 7 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 55022202 07613327101751

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention