BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RAPIDLOC IMPLANT

    MDR report key: 5916597 · Received August 31, 2016

    Report

    Report Number
    1221934-2016-10368
    Event Type
    Injury
    Date Received
    August 31, 2016
    Report Date
    August 1, 2016
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK MEDICAL SAFETY DEPARTMENT DISCOVERED THIS PUBLISHED WHITE PAPER DETAILING A HISTORICAL EVENT IN WHICH A MITEK DEVICE, RAPIDLOC MENISCAL REPAIR SYSTEM WAS IMPLICATED. IT CANNOT BE CONFIRMED THAT THESE INCIDENTS HAVE BEEN PREVIOUSLY REPORTED TO MITEK, SO AN ADVERSE EVENT REPORT IS BEING FILED TO DOCUMENT THE INCIDENTS DESCRIBED IN THE ARTICLE. FORTY ONE PATIENTS UNDERWENT REVISION SURGERY WITHIN A 6 MONTH TO 2 YEAR TIME PERIOD FROM THE ORIGINAL SURGERY. THE AUTHOR HAS BEEN CONTACTED FOR ADDITIONAL INFORMATION ABOUT THE PATIENTS AND INDIVIDUAL INCIDENTS BUT NONE HAS BEEN RECEIVED THUS FAR. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. 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. UDI: UNAVAILABLE.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS FORWARDED TO MITEK PRODUCT COMPLAINTS FROM OUR MEDICAL SAFETY TEAM AFTER REVIEWING A JOURNAL ARTICLE IN KNEE SURG SPORTS TRAUMATOL ARTHROSC (2016) 24:1495-1500. IT INVOLVED A STUDY ON ¿LONG-TERM OUTCOME AFTER ALL-INSIDE MENISCAL REPAIR USING THE RAPIDLOC SYSTEM. IT WAS STATED 82 PATIENTS FULFILLED THE REQUIREMENTS FOR INCLUSION IN THE STUDY WITH 66 MALES AND 20 FEMALES WITH A MEDIAN AGE OF 33 YEARS. A STANDARDIZED TELEPHONE INTERVIEW WAS USED AS A FOLLOW UP ON THESE PATIENTS BETWEEN 7-12 YEARS AFTER THE PRIME MENISCAL REPAIR WAS PERFORMED. ONE PATIENT HAD A REPEAT SURGERY OF THE PREVIOUSLY REPAIRED MENISCUS WITHIN 6 MONTHS AFTER SURGERY. AUTHORS: EIRIK SOLHEIM, JANNE HEGNA, EIVIND INDERHAUG [email protected]. REFERENCE: (B)(6). WEB ADDRESS LOCATION FOR THE ARTICLE: HTTP://LINK.SPRINGER.COM/ARTICLE/10.1007/S00167-015-3642-4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569531 UNKNOWN RAPIDLOC IMPLANT MITEK MENISCAL IMPLANTS MBI DEPUY MITEK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other