BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVISION MODULAR NECK H.70MM

    MDR report key: 8486941 · Received April 5, 2019

    Report

    Report Number
    3008021110-2019-00032
    Event Type
    Injury
    Date Received
    April 5, 2019
    Date of Event
    March 5, 2019
    Report Date
    April 4, 2019
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    LZO
    PMA / PMN Number
    K151739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BY CHECKING THE MANUFACTURING CHARTS OF THE LOT#S OF THE INSTRUMENTS INVOLVED, NO ANOMALIES WERE FOUND. THIS IS THE FIRST AND ONLY COMPLAINT INVOLVING THESE LOT #S. WE WILL SUBMIT A FINAL REPORT AFTER FINAL INVESTIGATION.

    Description of Event or Problem · 1

    HIP REVISION SURGERY OCCURRED ON THE (B)(6) 2019. PREVIOUS SURGERY OCCURRED ON THE (B)(6) 2018 AND WAS A REVISION SURGERY TOO: DURING THIS SURGERY, THE REVISION STEM (CODE #3812.15.010 LOT #1604933), THE REVISION NECK (#7515.15.020, LOT#1700492) AND THE FEMORAL HEAD (#5010.42.282, LOT #1880074) BY LIMACORPORATE WERE IMPLANTED IN COMBINATION WITH AN ACETABULAR CUP BY ANOTHER COMPANY. IT WAS REPORTED THAT THE PATIENT HAS HAD REGULAR HIP PAIN SINCE SHE STARTED HAVING VERY STRONG PAIN, IMPOSSIBILITY TO PUT WEIGHT ON THE LEG AND AN EXTERNAL ROTATION OF 50 DEGREES. DURING THE LAST REVISION SURGERY, THE SCREW OF THE NECK WAS FOUND UNSCREWED AND THE NECK WAS NO LONGER ATTACHED TO THE STEM. FURTHERMORE, THE STEM WAS NOT OSSEOINTEGRATED. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280664 REVISION MODULAR NECK H.70MM REVISION MODULAR NECK H.70MM (LZO-LPH-KWY) LZO LIMACORPORATE SPA 7515.15.020 1700492

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention