BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS LATERAL TROCH BOLT 42MM

    MDR report key: 6885820 · Received September 22, 2017

    Report

    Report Number
    0001825034-2017-07179
    Event Type
    Injury
    Date Received
    September 22, 2017
    Date of Event
    September 23, 2015
    Report Date
    December 8, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED EVENT IS CONFIRMED. X-RAY REVIEW CONFIRMED THAT THE TROCHANTERIC BOLT/CLAW ASSEMBLY WAS DISASSOCIATED FROM THE PROXIMAL FEMORAL STEM BODY AND THE ASSEMBLED PARTS WERE DISPLACED POSTEROLATERALLY. THE REVIEW ALSO NOTED THAT THE STEM COMPONENTS WHICH WERE PROXIMAL AND DISTAL TO THE TAPER JUNCTION HAD NO PROPER FIXATION. WIDE ZONES OF PERIPROSTHETIC LUCENCY WAS OBSERVED THROUGHOUT THE REGION OF THE EXTENDED TROCHANTERIC OSTEOTOMY. THE BONE FRAGMENTATION IN VICINITIES OF THE GREATER TROCHANTER AND AT THE EXTENDED TROCHANTERIC OSTEOTOMY COULD HAVE OCCURED DUE TO FRACTURES. OSTEOPOROSIS COULD HAVE LED TO LOOSENING OF THE BOLT AND RESULTED IN THE DISASSOCIATION OF THE COMPONENTS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE COMPATIBILITY CHECK NOTED NO ISSUES. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034 - 2017 - 02010. 0001825034 - 2017 - 07179. CONCOMITANT PRODUCTS: 11-302102, ARCOS TROCH CLAW, L/N 085570. 11-302142, ARCOS LATERAL TROCH BOLT, L/N 398520. 22-300917, ARRCOS STT DIS STEM, L/N 504230. PT 103056, REGENEREX RINGLOC SHELL, L/N 360640. 163370, COCR 32 MM, 0073235778. EP053254, RINGLOC LINER, L/N 3276013. 22-301321, ARCOS CON SZ A STD, L/N 013730. REPORT SOURCE; FOREIGN. THE EVENT OCCURRED IN (B)(6). THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF PROVIDED PATIENT X-RAYS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND.REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN. THE CLAW PLATE WAS FOUND TO BE LOOSE AND DISLOCATED APPROXIMATELY THREE MONTHS POST IMPLANTATION. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666967 ARCOS LATERAL TROCH BOLT 42MM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 398520

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention