BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM -4 LFIT V40 HEAD

    MDR report key: 3781201 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01659
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    July 1, 2013
    Report Date
    July 1, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K010757
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. 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. AN X-RAY AND AN OPERATIVE REPORT WAS RECEIVED. THE OPERATIVE REPORT STATED A PRE AND POSTOPERATIVE DIAGNOSIS OF DISLOCATION OF THE RIGHT HIP. THE PATIENTS PRIMARY SURGERY WAS FOR A LONG STANDING ISSUE WITH THE KNEE. IT WAS NOTED THAT THE CUP WAS IN A GOOD POSITION. NO COMPLICATIONS WERE NOTED DURING SURGERY. A REVIEW OF THE PROVIDED X-RAY AND OPERATIVE REPORT COULD NOT DETERMINE A ROOT CAUSE. THE EVENT WAS CONFIRMED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS RETURN OF DEVICE, PRE- AND POST-OP XRAYS, PATIENT HISTORY & FOLLOW-UP NOTES ARE NEEDED TO INVESTIGATE THIS EVENT FURTHER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DISLOCATED AND THE SURGEON CHANGED THE CONSTRAINED LINER, FEMORAL COMPONENT AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259853 28MM -4 LFIT V40 HEAD IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH 40425308

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other