BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRINITY

    MDR report key: 24579301 · Received March 12, 2026

    Report

    Report Number
    9614209-2026-00036
    Event Type
    Injury
    Date Received
    March 12, 2026
    Date of Event
    February 26, 2026
    Report Date
    March 12, 2026
    Manufacturer
    CORIN LTD
    Product Code
    OQI
    UDI-DI
    05055343869840
    PMA / PMN Number
    K111481
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PER COMP 2377 INITIAL REPORT: ADDITIONAL INFORMATION INCLUDING: POST PRIMARY AND PRE REVISION X-RAYS. PHOTOGRAPHS OF THE EXPLANTED DEVICE. OPERATIVE NOTES (PRIMARY AND REVISION). PATIENT WEIGHT, ACTIVITY LEVEL AND MEDICAL HISTORY. DID THE PATIENT FOLLOW CORRECT POST-OP PROTOCOL? DID THE PATIENT EXPERIENCE ANY SLIPS / FALLS OR OTHER TRAUMA POST PRIMARY SURGERY? AN UPDATE ON THE PATIENT POST REVISION. ANY PATIENT SPECIFIC ANATOMIES WHICH MAY HAVE IMPACTED THE CUP ORIENTATION. ANY SPECIFIC PATIENT ACTIVITIES WHICH WOULD LEAD TO EXTREME RANGE OF MOTION. WHETHER THERE WAS ANY DAMAGE NOTED ON THE STEM DURING THE REVISION? WAS THIS AN OPS PATIENT - WERE ANY ISSUES WITH DISLOCATION/ IMPINGEMENT ANTICIPATED? WHY WAS AN EPW LINER CHOSEN FOR THIS PATIENT? WHAT POSITION WAS THE ELEVATED WALL PLACED? 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 RELEVANT DEVICE MANUFACTURING RECORDS WILL BE IDENTIFIED AND REVIEWED. CONCLUSIONS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. 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 OCCURED OUTSIDE OF THE USA. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OF DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    TRINITY REVISION OF THE CUP, ECIMA LINER, BIOLOX DELTA CERAMIC HEAD AND SCREW AFTER APPROXIMATELY 1 YEAR AND 6 MONTHS. THE ECIMA LINER WAS LOOSE AND HAD FRACTURED THROUGH THE POSTERIOR RIM AND EPW JUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638184 TRINITY ACETABULAR SYSTEM ECIMA LINER OQI CORIN LTD 322.02.932 521587 05055343869840

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R TRINITY BIOLOX DELTA CERAMIC HEAD: 104.3605, 534337.| TRINITY CUP: 321.02.346, 538636.| TRINITY SCREW: 321.0200, 548593.