BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRINITY

    MDR report key: 16451987 · Received February 28, 2023

    Report

    Report Number
    9614209-2023-00164
    Event Type
    Injury
    Date Received
    February 28, 2023
    Date of Event
    February 13, 2023
    Report Date
    February 28, 2023
    Manufacturer
    CORIN LTD (UK & FR)
    Product Code
    MEH
    PMA / PMN Number
    K111481
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMBINED REPORT: ADDITIONAL INFORMATION, INCLUDING POST PRIMARY AND PRE REVISION X-RAYS, OPERATIVE NOTES (PRIMARY AND REVISION), PATIENT DETAILS, PATIENT MEDICAL HISTORY, WHAT THE PATIENT WAS DOING AT THE TIME OF THE DISLOCATION, WHETHER THE PATIENT FOLLOWED CORRECT POST-OP PROTOCOL, WHETHER THE PATIENT EXPERIENCED ANY SLIPS / FALLS OR OTHER TRAUMA POST PRIMARY SURGERY AND AN UPDATE ON THE PATIENT POST REVISION, WAS REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT, HOWEVER, NOT ALL INFORMATION COULD 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. REVIEW OF THESE RECORDS REVEALED NO DEVIATION FROM PROCESS OR PRODUCT NON-CONFORMITY THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. 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

    LEFT SIDE REVISION HIP SURGERY AFTER APPROXIMATELY 1 MONTH DUE TO DISLOCATION. CUP, LINER AND COMPETITOR HEAD REVISED. COMPETITOR STEM REMAINS IN-SITU. PRODUCT INFO: 1. TRINITY CUP 48MM TAPER SIZE 2 -- PART #: 321.02.348 -- ARTG #: 235377 -- LOT #: 497601 (EXPLANTED). 2. TRINITY ECIMA LINER TAPER 2 32MM NEUTRAL -- PART #: 322.02.632 -- ARTG #: 210775 -- LOT #: 513598 (EXPLANTED). 3. OPS INSIGHT -- PART #: 1200-0000 -- ARTG #: 323911 -- LOT #: MOR_MO_69390. 4. OPS ACETABULAR GUIDE -- PART #: 1248-0500 -- ARTG #: N/A -- LOT #: MOR_MO_69390. PRIMARY SURGERY INFO: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799177 TRINITY ACETABULAR HIP SYSTEM WITH ECIMA LINERS MEH CORIN LTD (UK & FR) 321.02.348 497601

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R TRINITY CUP: 321.02.348, 497601.