BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMET

    MDR report key: 7776132 · Received August 13, 2018

    Report

    Report Number
    9614209-2018-00060
    Event Type
    Injury
    Date Received
    August 13, 2018
    Date of Event
    May 16, 2016
    Report Date
    March 10, 2020
    Manufacturer
    CORIN GROUP
    Product Code
    NXT
    PMA / PMN Number
    P050016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PER -1300 FINAL REPORT: IN ORDER TO CONDUCT A THOROUGH INVESTIGATION OF THE EVENT, OPERATIVE NOTES, PATIENT AGE, ACTIVITY LEVEL, PATIENT MEDICAL HISTORY, AVAILABLE X-RAYS, A DETAILED PATIENT OUTCOME FOLLOWING THE REVISION AND DEVICES RETURN WERE REQUESTED . NO ADDITIONAL INFORMATION WAS PROVIDED. THE APPROPRIATE DEVICE DETAILS HAVE BEEN PROVIDED AND THE AVAILABLE DEVICE MANUFACTURING RECORDS WERE IDENTIFIED AND REVIEWED. THE IMPLANTED DEVICES CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURE. WITHOUT MORE INFORMATION, NO FURTHER INVESTIGATION CAN BE PERFORMED. BASED ON THIS, CORIN NOW CONSIDERS THIS CASE CLOSED. HOWEVER, SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE FOR THIS EVENT, THIS CASE MAY BE RE-OPENED FOR FURTHER INVESTIGATION. PLEASE NOTE : THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    CORMET REVISION OF THE LEFT HIP IN A BI-LATERAL PATIENT AFTER APPROXIMATELY 6 YEARS AND 9 MONTHS. PLEASE NOTE: THIS PATIENT ALSO HAD A REVISION OF THE RIGHT HIP (SEE REPORT 9614209-2018-00059).

    Additional Manufacturer Narrative · 1

    PER -1300 INITIAL REPORT. ADDITIONAL INFORMATION, INCLUDING THE REASON FOR REVISION, POST PRIMARY AND PRE REVISION X-RAYS, OPERATIVE NOTES, PATIENT AGE AND ACTIVITY LEVEL, PATIENT MEDICAL HISTORY, A DETAILED PATIENT OUTCOME AND THE RETURN OF THE EXPLANTED DEVICES HAS BEEN REQUESTED IN ORDER TO PROGRESS WITH THIS INVESTIGATION, AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE APPROPRIATE DEVICE DETAILS HAVE BEEN PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WILL BE IDENTIFIED AND REVIEWED.

    Description of Event or Problem · 1

    CORMET REVISION OF THE LEFT HIP IN A BI-LATERAL PATIENT AFTER APPROXIMATELY 6 YEARS AND 9 MONTHS. PLEASE NOTE: THIS PATIENT ALSO HAD A REVISION OF THE RIGHT HIP (SEE REPORT 9614209-2018-00059).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619503 CORMET HIP RESURFACING PROSTHESIS NXT CORIN GROUP 571-04-044 LOTO

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R CORMET CUP - 570-04-050, LBTE| CORMET CUP - 570-04-050, LBTE| CORMET CUP - 570-04-050, LBTE