BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERFIT

    MDR report key: 6867898 · Received September 15, 2017

    Report

    Report Number
    9614209-2017-00066
    Event Type
    Injury
    Date Received
    September 15, 2017
    Date of Event
    August 28, 2017
    Report Date
    March 8, 2018
    Manufacturer
    CORIN MEDICAL
    Product Code
    JDI
    PMA / PMN Number
    K92234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (9)(4) INITIAL REPORT. CORIN HAVE RECEIVED NOTIFICATION THAT A PATIENT IMPLANTED WITH TRINITY AND TAPERFIT DEVICES HAS DISLOCATED FOLLOWING THE PRIMARY SURGERY ON (B)(6) 2017. THE PATIENT WILL REQUIRE A CLOSED REDUCTION OR A REVISION, IT IS UNKNOWN AT THIS TIME WHETHER A DEVICE REVISION HAS OCCURRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER, IT HAS BEEN CONFIRMED THAT NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME. THE APPROPRIATE DEVICE DETAILS HAVE BEEN PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WILL BE IDENTIFIED AND REVIEWED. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN ADVERSE EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT HAS OCCURRED OUTSIDE OF THE USA.

    Additional Manufacturer Narrative · 1

    (B)(4) FINAL REPORT. CORIN RECEIVED NOTIFICATION THAT A PATIENT IMPLANTED WITH TRINITY AND METAFIX DEVICES DISLOCATED FOLLOWING PRIMARY SURGERY ON (B)(6) 2017. THE PATIENT REQUIRED A CLOSED REDUCTION OR A REVISION. IT IS UNKNOWN WHETHER A DEVICE REVISION HAS OCCURRED. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER, IT WAS CONFIRMED THAT NO FURTHER INFORMATION WOULD BE AVAILABLE FOR THIS EVENT. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS HAVE BEEN IDENTIFIED AND REVIEWED. ALL PARTS ASSOCIATED WITH THESE RECORDS CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION. BASED ON THE INFORMATION AVAILABLE, NO FURTHER INVESTIGATION CAN BE CONDUCTED AT THUS CORIN NOW CONSIDER THIS CASE CLOSED, HOWEVER, SHOULD ADDITIONAL INFORMATION BE PROVIDED, THEN THIS CASE MAY BE RE-OPENED FOR FURTHER INVESTIGATION. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN ADVERSE EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA.

    Description of Event or Problem · 1

    CORIN HAVE BEEN INFORMED THAT A PATIENT IMPLANTED WITH TRINITY AND TAPERFIT DEVICES WILL REQUIRE A CLOSED REDUCTION OR A DEVICE REVISION DUE TO DISLOCATION.

    Description of Event or Problem · 1

    CORIN HAVE BEEN NOTIFIED THAT A PATIENT IMPLANTED WITH TRINITY / METAFIX DEVICES WILL REQUIRE A CLOSED REDUCTION OR A DEVICE REVISION DUE TO DISLOCATION. PLEASE NOTE: IT HAS NOT BEEN CONFIRMED THAT A CLOSED REDUCTION OR REVISION HAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650764 TAPERFIT TOTAL HIP SYSTEM JDI CORIN MEDICAL 588.3800 351600

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R BILOX CERAMIC HEAD - 104.3205, 355291| CEMENT RESTRICTOR - 588.0001, 353168| TRINITY CUP - 321.02.348, 352201| TRINITY ECIMA LINER - 322.02.632, 345224