BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY CUP POSITIONER CAP

    MDR report key: 19011633 · Received April 1, 2024

    Report

    Report Number
    0001822565-2024-01092
    Event Type
    Malfunction
    Date Received
    April 1, 2024
    Date of Event
    March 14, 2024
    Report Date
    September 6, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KIL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) D2: PRODUCT CODE: KIL D10: MEDICAL PRODUCT: CUP POSITIONER: CATALOG#00626001800, LOT#NI; SHELL POROUS WITH MULTI HOLES 40 MM: CATALOG#00620204020, LOT#NI. G2: FOREIGN: GERMANY MULTIPLE MDR REPORTS HAVE BEEN FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001822565-2024-01090; 0001822565-2024-01091. DILIGENCE IS IN PROCESS TO DETERMINE WHETHER THE PRODUCT IS AVAILABLE FOR EVALUATION. THE INVESTIGATION IS IN PROGRESS. UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4; B5; G3; H2; H6; H11. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE TIP OF THE INSERTER WITH SOME DAMAGE NOTED TO THE THREADS. A FULL VIEW OF THE THREADED TIP WAS NOT PROVIDED TO CONFIRM THE FRACTURE. NO FURTHER EVALUATION CAN BE MADE FROM THE PROVIDED PICTURE. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TOTAL HIP ARTHROPLASTY PROCEDURE, THE CUP INSERTER WOULD NOT RELEASE FROM THE CUP DURING IMPLANTATION. THE SHELL HAD TO BE FORCIBLY REMOVED FROM THE PATIENT. THE DEVICES WERE ABLE TO BE SEPARATED OUTSIDE OF THE PATIENT, HOWEVER THE THREAD OF THE INSERTER FRACTURED IN THE CUP, RENDERING IT UNUSABLE. A COMPETITOR DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A THIRTY (30) MINUTE SURGICAL DELAY AS A RESULT OF THE MALFUNCTION HOWEVER NO PATIENT IMPACT OR ADVERSE EVENTS HAVE BEEN REPORTED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1518261 TRILOGY CUP POSITIONER CAP POSITIONER, SOCKET KIL ZIMMER BIOMET, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose SEE H10 NARRATIVE.