BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRINITY

    MDR report key: 15968535 · Received December 13, 2022

    Report

    Report Number
    9614209-2022-00137
    Event Type
    Injury
    Date Received
    December 13, 2022
    Date of Event
    December 1, 2022
    Report Date
    February 28, 2023
    Manufacturer
    CORIN LTD
    Product Code
    LZO
    PMA / PMN Number
    K103120
    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 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 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. 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 SPECIFICATION AT THE TIME OF MANUFACTURE. 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 DUE TO DISLOCATION. PATIENT ORIGINAL SURGERY DATE (B)(6) 2019 - WEBOPS CASE # (B)(4) (NON-OPS). (B)(6) HOSPITAL. DR (B)(6). PATIENT DISLOCATED ON (B)(6) 2022. REVISION OF LINER AND FEMORAL HEAD (B)(6) 2022. PRODUCTS INVOLVED: CERAMIC HEAD MEDIUM 36MM +0MM. PART # 104.3605. LOT # 417307. ARTG # 211371. TRINITY ECIMA LINER TAPER 3 36MM NEUTRAL. PART # 322.03.636. LOT # 409890. ARTG # 210775. TRINITY CUP 50MM TAPER SIZE 3. PART # 321.03.350. LOT # 406068. ARTG # 235377. METAFIX COLLARED STD 125 SIZE 3. PART # 579.2103. LOT # 399397. ARTG # 281110

    Description of Event or Problem · 0

    TRINITY REVISION OF THE ECIMA LINER AND BIOLOX DELTA CERAMIC HEAD AFTER APPROXIMATELY 3 YEARS AND 8 MONTHS DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386670 TRINITY BIOLOX DELTA CERAMIC HEAD LZO CORIN LTD 104.3605 417307

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention| H METAFIX COLLARED STEM: 579.2103, 399397| TRINITY ECIMA LINER: 322.03.636, 409890| TRINITY ECIMA LINER: 322.03.636, 409890| TRINITY-I CUP: 321.03.350, 406068