BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GRYPHON

    MDR report key: 7522235 · Received May 17, 2018

    Report

    Report Number
    1221934-2018-50670
    Event Type
    Injury
    Date Received
    May 17, 2018
    Date of Event
    February 24, 2014
    Report Date
    April 17, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. EVALUATION STATEMENT: THE COMPLAINT DEVICE IS NOT AVAILABLE FOR PHYSICAL EVALUATION, HENCE, THE COMPLAINT CANNOT BE CONFIRMED. GIVEN THE INFORMATION PROVIDED WE CANNOT DISCERN A DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE. NO VALID MITEK PART OR LOT NUMBERS WERE SUPPLIED WHICH PRECLUDES CONDUCTING A DEVICE HISTORY RECORD (DHR) REVIEW. AT THIS POINT, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. DEPUY SYNTHES HAS BEEN INFORMED THAT THE CATALOG NUMBER AND LOT NUMBER ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: RESULTS OF ARTHROSCOPIC BANKART REPAIR WITH HILL-SACHS REMPLISSAGE FOR ANTERIOR SHOULDER INSTABILITY AUTHORS: NICOLAS BONNEVIALLE AND ET AL INTERNATIONAL ORTHOPAEDICS (SICOT) (2017) 41:2573-2580 DOI 10.1007/S00264-017-3491-5 [email protected] DEPARTEMENT D'ORTHOPEDIE TRAUMATOLOGIE DU CHU DE TOULOUSE, HOPITAL RIQUET, PLACE BAYLAC, 31052 TOULOUSE, FRANCE. DEPUY MITEK HAS BEEN INFORMED THAT THE CATALOG NUMBER AND LOT NUMBER ARE NOT AVAILABLE.

    Description of Event or Problem · 1

    THIS REPORT WAS DERIVED FROM A JOURNAL ARTICLE STATING: OSTEOLYSIS AROUND THE ANCHORS USED FOR THE REMPLISSAGE WAS IDENTIFIED IN TWO CASES ON BERNAGEAU VIEW, WITHOUT CLINICAL CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366918 UNKNOWN GRYPHON UNKNOWN GRYPHON MAI DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other