BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3653081 · Received February 28, 2014

    Report

    Report Number
    0002249697-2014-00584
    Event Type
    Injury
    Date Received
    February 28, 2014
    Date of Event
    February 5, 2014
    Report Date
    February 5, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN STEM. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS SENT TO PATHOLOGY PER OR PROTOCOL AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PERIPROSTHETIC FRACTURE INVOLVING A UNKNOWN FEMORAL STEM WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR IDENTIFICATION OR EVALUATION. -MEDICAL RECORDS RECEIVED AND EVALUATION: A MEDICAL CONSULTANT REVIEWED THE AVAILABLE INFORMATION AND INDICATED THAT ¿PERIPROSTHETIC FRACTURE NOTED ON X-RAY. NEED OP REPORTS AND CLINICAL HISTORY.¿ -DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. -COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. CONCLUSIONS: NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND / OR INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    PATIENT PRESENT TO DR. (B)(6) OFFICE WITH PAIN. X-RAY REVEALS A PERI PROSTHETIC FX OF LEFT HIP. DR. (B)(6) DECIDED TO REVISE WITH A LONGER STEM THROUGH THE ANTERIOR APPROACH. DR. (B)(6) REMOVED THE STEM AND IMPLANTED A RESTORATION MODULAR STEM. HE REPLACED THE 36MM HEAD TO ADJUST LEG LENGTH AND CLOSED SURGICAL SITE.

    Description of Event or Problem · 1

    PATIENT PRESENT TO DR (B)(6) OFFICE WITH PAIN. X-RAY REVEALS A PERI PROSTHETIC FX OF LEFT HIP. DR. J. DECIDED TO REVISE WITH A LONGER STEM THROUGH THE ANTERIOR APPROACH. DR (B)(6) REMOVED THE STEM AND IMPLANTED A RESTORATION MODULAR STEM. HE REPLACED THE 36MM HEAD TO ADJUST LEG LENGTH AND CLOSED SURGICAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123183 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT KWL STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention