BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFLEX M-HA HIP STEM

    MDR report key: 4263747 · Received November 20, 2014

    Report

    Report Number
    0002249697-2014-04345
    Event Type
    Injury
    Date Received
    November 20, 2014
    Date of Event
    October 28, 2014
    Report Date
    October 28, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWL
    PMA / PMN Number
    K920193
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. PATIENT REQUESTED.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. THE EXACT CAUSE OF THE REPORTED PAIN COULD NOT BE DETERMINED. BASED ON THE INFORMATION PROVIDED THERE IS NO EVIDENCE THE EVENT IS DEVICE RELATED. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED PAIN MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE. 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, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    PATIENT COMPLAINED OF PAIN IN LEFT HIP. X-RAY AND MRI REVEALED A LUCENCY IN THE MEDIAL PROXIMAL FEMUR. FEMORAL COMPONENT MINUS THE DISTAL TIP WAS REMOVED. AFTER NUMEROUS ATTEMPTS TO EXTRACT DISTAL TIP IN CANAL, SURGEON DECISION WAS TO PUSH TIP MORE DISTALLY AND LEAVE IN. THIS ALLOWED ROOM TO IMPLANT A 195MM MOD RESTORATION CONICAL STEM. THE ACETABULAR INSERT WAS REMOVED AND A TRIDENT 40MM LINER WAS CEMENTED INTO THE CUP, SINCE THE 40MM WAS NOT AN AVAILABLE OPTION.

    Description of Event or Problem · 1

    PATIENT COMPLAINED OF PAIN IN LEFT HIP. X-RAY AND MRI REVEALED A LUCENCY IN THE MEDIAL PROXIMAL FEMUR. FEMORAL COMPONENT MINUS THE DISTAL TIP WAS REMOVED. AFTER NUMEROUS ATTEMPTS TO EXTRACT DISTAL TIP IN CANAL, SURGEON DECISION WAS TO PUSH TIP MORE DISTALLY AND LEAVE IN. THIS ALLOWED ROOM TO IMPLANT A 195MM MOD RESTORATION CONICAL STEM. THE ACETABULAR INSERT WAS REMOVED AND A TRIDENT 40MM LINER WAS CEMENTED INTO THE CUP, SINCE THE 40MM WAS NOT AN AVAILABLE OPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754231 OMNIFLEX M-HA HIP STEM IMPLANT KWL STRYKER ORTHOPAEDICS-MAHWAH 1842070X

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention