BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL STEM KAR14 HAC

    MDR report key: 6687149 · Received July 5, 2017

    Report

    Report Number
    1818910-2017-20582
    Event Type
    Injury
    Date Received
    July 5, 2017
    Date of Event
    June 5, 2017
    Report Date
    June 5, 2017
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    LZO
    PMA / PMN Number
    K961732
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. (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 · 1

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM, BONE TO IMPLANT INTERFACE. IT WAS ALSO INDICATED THAT PATIENT HAD A LONG CORAIL REV STEM THAT CRACKED DISTALLY, THE BROKEN PIECES WERE REMOVED AND A PROSTALAC SPACER WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468510 CORAIL STEM KAR14 HAC HIP FEMORAL STEM/SLEEVE LZO DEPUY FRANCE SAS 3003895575 5019966

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention