BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY ACETABULAR SYSTEM SHELL WITH HOLES POROUS 46 MM

    MDR report key: 7332075 · Received March 12, 2018

    Report

    Report Number
    0001822565-2018-01456
    Event Type
    Injury
    Date Received
    March 12, 2018
    Date of Event
    February 23, 2017
    Report Date
    March 12, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK934765
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) IMPLANTED DATE- SOMETIME IN 1998. CONCOMITANT MEDICAL PRODUCTS: 00612004626 52166200 LINER 26 MM I.D. FOR USE WITH 46 MM O.D. SHELL 20 DEG. ELEVATED RIM, 163620 116880 26 MM DIA COCR MOD HD -6 MM NK NO SKIRT, 11-104106 897900 MLRY-HD POR FMRL 6 X 135 MM. (B)(6). X-RAYS WERE EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. NO SIGNS OF RADIOLUCENCY AND NO FRACTURE SEEN. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2017-01838.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT¿S HIP WAS REVISED APPROXIMATELY 9 YEARS POST IMPLANTATION DUE TO OSTEOLYSIS, POLYWEAR, LOOSENING AND BONE FRACTURE 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
    175282 TRILOGY ACETABULAR SYSTEM SHELL WITH HOLES POROUS 46 MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 62641500

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R