BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRINITY DUAL MOBILITY

    MDR report key: 12238111 · Received July 28, 2021

    Report

    Report Number
    9614209-2021-00091
    Event Type
    Injury
    Date Received
    July 28, 2021
    Date of Event
    July 15, 2021
    Report Date
    October 8, 2021
    Manufacturer
    CORIN MEDICAL
    Product Code
    LZO
    PMA / PMN Number
    K170359
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PER -3976 FINAL REPORT. ADDITIONAL INFORMATION, INCLUDING OPERATIVE NOTES, PATIENT MEDICAL HISTORY AND AN UPDATE ON THE PATIENT POST REVISION WAS REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT, HOWEVER, THIS INFORMATION WAS NOT PROVIDED. 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 AT THE TIME OF MANUFACTURE. THERE HAS NOT BEEN A MALFUNCTION OR FAILURE OF THE CORIN DEVICES AND THE TRINITY DUAL MOBILITY ECIMA INSERT WAS ONLY REVISED DUE TO LOOSENING OF THE NON-CORIN STEM AND THUS NO FURTHER INVESTIGATION IS REQUIRED. THEREFORE, THIS CASE IS NOW CONSIDERED CLOSED. 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. 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

    REVISION OF A TRINITY DUAL MOBILITY ECIMA INSERT, A NON-CORIN HEAD AND NON-CORIN STEM AFTER APPROXIMATELY 8 MONTHS DUE TO PAIN AND LOOSENING OF THE NON-CORIN STEM.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION, INCLUDING OPERATIVE NOTES, PATIENT MEDICAL HISTORY AND AN UPDATE ON THE PATIENT POST REVISION HAS BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT, 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. 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. 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 · 1

    REVISION OF A TRINITY DUAL MOBILITY ECIMA INSERT, A NON-CORIN HEAD AND NON-CORIN STEM AFTER APPROXIMATELY 8 MONTHS DUE TO STEM LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134111 TRINITY DUAL MOBILITY ACETABULAR HI SYSTEM LZO CORIN MEDICAL 325.04.042 440598

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R NON-CORIN HEAD| NON-CORIN HEAD| NON-CORIN STEM| NON-CORIN STEM| TRINITY CUP: 321.04.356, 451064| TRINITY CUP: 321.04.356, 451064| TRINITY DM COCR LINER: 321.04.540, 438193| TRINITY DM COCR LINER: 321.04.540, 438193| NON-CORIN HEAD| NON-CORIN STEM| TRINITY CUP: 321.04.356, 451064| TRINITY DM COCR LINER: 321.04.540, 438193