BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS HA MODULAR REVISION SYSTEM CONE PROX BODY / TY I TAPER SZ A HIGH OFFSET 70

    MDR report key: 6017599 · Received October 11, 2016

    Report

    Report Number
    0001825034-2016-04055
    Event Type
    Injury
    Date Received
    October 11, 2016
    Date of Event
    June 10, 2016
    Report Date
    March 19, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 9 STATES "FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-04055 / 04056). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET IN (B)(4), IN AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K090757.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 22-301918 ARCOS INTLK DIST STM TI BM/PC 18MMX250MM 251730, 166069 ARCOS DISTAL SCREW TI 5X45MM 1829580, 166070 ARCOS DISTAL SCREW TI 5X50MM 1829586. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED PRODUCTS CONFIRMS THE DAMAGES AND FRACTURE OF THE IMPLANT. X-RAY REVIEW INDICATES THAT THE STEM ON THE PROXIMAL SIDE OF THE FRACTURE DOES NOT HAVE FIXATION. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION SURGERY APPROXIMATELY 4 YEARS POST-IMPLANTATION DUE FRACTURE OF METAPHYSEAL COMPONENT OF THE MODULAR STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667811 ARCOS HA MODULAR REVISION SYSTEM CONE PROX BODY / TY I TAPER SZ A HIGH OFFSET 70 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 915820

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R