BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS 19X190MM SPL TPR DIST

    MDR report key: 7272024 · Received February 14, 2018

    Report

    Report Number
    0001825034-2018-00994
    Event Type
    Injury
    Date Received
    February 14, 2018
    Date of Event
    November 2, 2016
    Report Date
    May 4, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). CONCOMITANT PRODUCTS: PM156556 PECK RT TFLANGE SZ24 784760;  11-300919 ARCOS 19X190MM SPL TPR DIST 649370;   103538  TI LOW PROFILE SCREW 6.5X60MM 644450 ; 103537  TI LOW PROFILE SCREW 6.5X50MM 618190 ; 103533  TI LOW PROFILE SCREW 6.5X30MM 841500 ; 103533  TI LOW PROFILE SCREW 6.5X30MM 405510 ; 11-107323 FREEDOM STD FACE LINER SZ 24 845130 ; 11-107023 FREEDOM CONSTR. LINER +5 SZ 24 821570 ; 11-107021 FREEDOM CONSTR HD 36MM T1 +9MM 273000 ; 103534  TI LOW PROFILE SCREW 6.5X35MM 625050;  103534  TI LOW PROFILE SCREW 6.5X35MM 388940 ; 103534  TI LOW PROFILE SCREW 6.5X35MM 863980 ; 103539  TI LOW PROFILE SCREW 6.5X70MM 527170 ; 103535  TI LOW PROFILE SCREW 6.5X40MM 864000. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-00993.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. X-RAYS REVIEW BY RADIOLOGIST STATES AP FILM OF THE RIGHT HIP WHICH DEMONSTRATES A RIGHT TOTAL HIP ARTHROPLASTY WITH SCREW FIXATION. NO DISLOCATION. HETEROTOPIC OSSIFICATION SURROUNDING THE RIGHT HIP. BONY LUCENCY AT THE GREATER TROCHANTER AND RADIOLUCENCY ALONG THE FEMORAL STEM WERE NOTED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RADIOLUCENCY LINES WERE SEE ON RIGHT HIP AFTER 3 YEARS 6 MONTHS POST REVISION SURGERY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113837 ARCOS 19X190MM SPL TPR DIST PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 649370

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other