BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY SHELL

    MDR report key: 10521742 · Received September 11, 2020

    Report

    Report Number
    0002648920-2020-00402
    Event Type
    Injury
    Date Received
    September 11, 2020
    Date of Event
    May 6, 2019
    Report Date
    September 10, 2020
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    PMA / PMN Number
    K934765
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: 00801803203 ¿ VERSYS HEAD ¿ 62971087; 00630505032 ¿ LINER ¿ 62954854; 0106010104 ¿ AVENIR STEM ¿ 4021833; 00625006535 ¿ BONE SCREW - 62964047. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS NOTING THAT PATIENT HAD ADVERSE LOCAL TISSUE REACTION SECONDARY TO TRIBOCORROSION STATUS POST RIGHT HIP TOTAL ARTHROPLASTY. A PSEUDOTUMOR FILLED WITH FLUID WAS NOTED ALONG WITH CORROSION PRESENT INSIDE THE HEAD AND STAINING ON THE FEMORAL NECK. OSTEOLYSIS AROUND THE RIM OF THE SHELL WAS FOUND HOWEVER THE SHELL WAS WELL FIXED AND IN GOOD POSITION. THERE WAS MILD PROXIMAL OSTEOLYSIS AROUND THE FEMORAL COMPONENT WHICH WAS DEBRIDED AWAY. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE IS UNABLE TO BE DETERMINED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0002648920 - 2019 - 00337. 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 PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 4 YEARS POST IMPLANTATION DUE TO ELEVATED METAL ION LEVELS, PSEUDOTUMOR, ALTR, IN-VIVO CORROSION AND OSTEOLYSIS. THE HEAD AND LINER WERE REMOVED AND REPLACED. 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
    985477 TRILOGY SHELL PROSTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. N/A 62845919

    Patients

    Seq Age Sex Outcome Treatment
    1 Other