BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY LINER

    MDR report key: 6432881 · Received March 24, 2017

    Report

    Report Number
    0001822565-2017-01838
    Event Type
    Injury
    Date Received
    March 24, 2017
    Date of Event
    February 23, 2017
    Report Date
    March 12, 2018
    Manufacturer
    ZIMMER, 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

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION TO THE CAUSE OF THE EVENT. (B)(6). CONCOMITANT PRODUCTS: SHELL POROUS WITH HOLES/ PN 00620004620/ LN 62641500.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 163620 116880 26MM DIA COCR MOD HD -6MM NK NO SKIRT. 11-104106 897900 MLRY-HD POR FMRL 6X135MM. REPORT SOURCE: (B)(6). REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. RIGHT TOTAL HIP ARTHROPLASTY WITH AN ASYMMETRIC POSITION OF THE FEMORAL HEAD WITHIN THE ACETABULAR CUP, LIKELY RELATED TO POLYETHYLENE WEAR. ALIGNMENT IS ABNORMAL AS THERE APPEARS TO LINER WEAR AND SUPER SUBLUXATION OF THE FEMORAL HEAD WITHIN THE ACETABULAR CUP. 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. INVESTIGATION RESULTS CONCLUDED THAT THE LIKELY ROOT CAUSE FOR THE LINER WEAR IS DUE TO WEAR AND TEAR. 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 A PATIENT UNDERWENT A HIP REVISION DUE TO OSTEOLYSIS AND POLYWEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212895 TRILOGY LINER HIP PROSTHESIS LPH ZIMMER, INC. N/A 52166200

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R