BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORAIL AMT SZ9 135 LOW COL

    MDR report key: 13635711 · Received March 1, 2022

    Report

    Report Number
    1818910-2022-03842
    Event Type
    Malfunction
    Date Received
    March 1, 2022
    Date of Event
    February 15, 2022
    Report Date
    March 1, 2022
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    LZO
    UDI-DI
    10603295455431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : A MANUFACTURING RECORD EVALUATION (NC SEARCH) WAS PERFORMED FOR THE FINISHED DEVICE L971309, LOT - 9602839, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE BHA FOR FEMORAL NECK BONE FRACTURE WITH THE STEM IN QUESTION. IN THE SURGERY, IT WAS DIFFICULT TO OPEN THE PACKAGE BECAUSE THE SEALING OF THE PACKAGE WAS STRONG, AND THE PAPER ADHERED TO THE CLEAN AREA. THE LABEL REMAINED ON THE IMPLANT WHILE TAKING OUT. THE IMPLANT WAS TAKEN OUT WITH KOCHER FORCEPS, BUT THE SURGEON CONSIDERED IT TO BE UNCLEAN. THEREFORE, THE STEM WAS DISCARDED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1303824 CORAIL AMT SZ9 135 LOW COL CORAIL LINE EXTENSION IMPLANTS : HIP FEMORAL STEM LZO DEPUY FRANCE SAS - 3003895575 L971309 9602839 10603295455431

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown