BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LATARJET PRODUCT

    MDR report key: 5990690 · Received September 30, 2016

    Report

    Report Number
    1221934-2016-10412
    Event Type
    Injury
    Date Received
    September 30, 2016
    Report Date
    September 1, 2016
    Manufacturer
    DEPUY MITEK
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) MEDICAL SAFETY DEPARTMENT DISCOVERED THIS PUBLISHED WHITE PAPER DETAILING A HISTORICAL EVENT IN WHICH SOME (B)(4) DEVICES WERE IMPLICATED. IT CANNOT BE CONFIRMED THAT THIS ISSUE HAD BEEN PREVIOUSLY REPORTED TO MITEK, SO AN ADVERSE EVENT REPORT IS BEING FILED TO DOCUMENT THE EXPERIENCE DESCRIBED IN THE ARTICLE. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, THIS FILE WILL REMAINS RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. (B)(4) 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE LOT EXPIRATION DATE AND PRODUCT CODE IS NOT AVAILABLE CURRENTLY. ASSOCIATED MEDWATCH: 1221934-2016-10411.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: GRAFT POSITION AND FUSION RATE FOLLOWING ARTHROSCOPIC LATARJET. AUTHORS: CASABIANCA, LAURENT AND ET AL KNEE SURG SPORTS TRAUMATOL ARTHROSC (2016) 24:507-512 DOI 10.1007/S00167-015-3551-6. (B)(6). N=1 GRAFT FRACTURE DUE TO AN INAPPROPRIATE CORACOID PREPARATION. N=1 EARLY CASE OF OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642611 UNK LATARJET PRODUCT SOFT-TISSUE, ANCHOR, NON-BIOABSORBABLE HWC DEPUY MITEK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other