BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA

    MDR report key: 10829148 · Received November 12, 2020

    Report

    Report Number
    9614209-2020-00105
    Event Type
    Injury
    Date Received
    November 12, 2020
    Date of Event
    October 22, 2020
    Report Date
    November 12, 2020
    Manufacturer
    CORIN MEDICAL
    Product Code
    LZO
    PMA / PMN Number
    K103120
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER (B)(4) COMBINED REPORT. THE PATIENT REQUIRED A REVISION AFTER APPROXIMATELY 5 MONTHS DUE TO LOOSENING OF THE ACETABULAR CUP. THE CORIN BIOLOX DELTA CERAMIC HEAD WAS REVISED ALONG WITH THE CUP AND LINER WHICH ARE NOT CORIN DEVICES. THE CORIN TAPERFIT STEM HAS REMAINED IN SITU. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS HAVE BEEN IDENTIFIED AND REVIEWED. ALL FINISHED PARTS ASSOCIATED WITH THESE RECORDS CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION AT THE TIME OF MANUFACTURE. AS THIS REVISION WAS REQUIRED DUE TO LOOSENING OF THE CUP WHICH WAS A NON-CORIN DEVICE, NO FURTHER INVESTIGATION IS REQUIRED AND THUS 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.

    Description of Event or Problem · 1

    REVISION OF A TRINITY BIOLOX DELTA CERAMIC HEAD AFTER APPROXIMATELY 5 MONTHS DUE TO LOOSENING OF THE CUP WHICH IS A NON-CORIN DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1297472 BIOLOX DELTA BIOLOX DELTA CERAMIC HEAD LZO CORIN MEDICAL 104.2805 443731

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R TAPERFIT STEM - 588.3800, 446765