BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRINITY

    MDR report key: 15968584 · Received December 13, 2022

    Report

    Report Number
    9614209-2022-00138
    Event Type
    Injury
    Date Received
    December 13, 2022
    Date of Event
    November 28, 2022
    Report Date
    February 28, 2023
    Manufacturer
    CORIN LTD
    Product Code
    LZO
    PMA / PMN Number
    K093472
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) INITIAL REPORT: ADDITIONAL INFORMATION, INCLUDING POST PRIMARY AND PRE REVISION X-RAYS, OPERATIVE NOTES (PRIMARY AND REVISION), PATIENT ACTIVITY LEVEL AND MEDICAL HISTORY, WHAT THE PATIENT WAS DOING AT THE TIME OF THE DISLOCATION, WHETHER THE PATIENT EXPERIENCED ANY SLIPS / FALLS OR OTHER TRAUMA POST PRIMARY SURGERY, WHETHER THE PATIENT FOLLOWED CORRECT POST-OP PROTOCOL 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.

    Additional Manufacturer Narrative · 0

    (B)(4) FINAL REPORT ADDITIONAL INFORMATION, INCLUDING POST PRIMARY AND PRE REVISION X-RAYS, OPERATIVE NOTES (PRIMARY AND REVISION), PATIENT ACTIVITY LEVEL AND MEDICAL HISTORY, WHAT THE PATIENT WAS DOING AT THE TIME OF THE DISLOCATION, WHETHER THE PATIENT EXPERIENCED ANY SLIPS / FALLS OR OTHER TRAUMA POST PRIMARY SURGERY, WHETHER THE PATIENT FOLLOWED CORRECT POST-OP PROTOCOL AND AN UPDATE ON THE PATIENT POST REVISION WAS REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT, HOWEVER, THIS INFORMATION COULD NOT BE PROVIDED AND THUS THE SCOPE OF THE INVESTIGATION WAS LIMITED. IT WAS REPORTED THAT THE SURGEON BELIEVES THE VERSION OF THE NON-CORIN STEM WAS THE CAUSE OF THE DISLOCATION, HOWEVER, THIS HAS NOT BEEN CONFIRMED. 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. BASED ON THE AVAILABLE INFORMATION, NO FURTHER INVESTIGATION CAN BE CONDUCTED AND THE ROOT CAUSE OF THE REPORTED DISLOCATION COULD NOT BE DETERMINED. THEREFORE, THIS CASE IS NOW CONSIDERED CLOSED, HOWEVER, SHOULD ANY 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. 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

    TRINITY CUP REVISION - DISLOCATION. RIGHT SIDE REVISION HIP SURGERY DUE TO DISLOCATION. ALL IMPLANTS REMOVED. CUP, LINER, COMPETITOR HEAD AND COMPETITOR STEM EXPLANTED. PRODUCT INFO: TRINITY CUP 48MM TAPER SIZE 2 - PART # 321.02.348 - LOT # 507591 - ARTG # 235377 (EXPLANTED); TRINITY CERAMIC LINER 32MM TAPER 2 - PART # 321.02.432 - LOT # 486397 - ARTG # 210774 (EXPLANTED); OPS INSIGHT + ACE GUIDE - PART # 1200-0000, 1248-0500 - LOT # BOU_MO_70062. PRIMARY SURGERY INFO: DATE: (B)(6) 2022; CASE: (B)(6); HOSPITAL: (B)(6); SURGEON: DR (B)(6).

    Description of Event or Problem · 0

    TRINITY REVISION OF THE CUP AND CERAMIC LINER AFTER 4 DAYS DUE TO DISLOCATION. A NON-CORIN STEM AND HEAD WERE ALSO REVISED. PLEASE NOTE: THE TRINITY BIOLOX DELTA CERAMIC LINER ASSOCIATED WITH THIS REPORT IS NOT CLEARED FOR SALE OR DISTRIBUTION IN THE USA AND THIS EVENT OCCURRED OUTSIDE OF THE USA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2145781 TRINITY ACETABULAR HIP SYSTEM LZO CORIN LTD 321.02.348 507591

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention| H BIOLOX DELTA CERAMIC LINER: 321.02.432 , 486397| BIOLOX DELTA CERAMIC LINER: 321.02.432, 486397