BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_TRIDENT 36D 0DG LINER

    MDR report key: 14982373 · Received July 11, 2022

    Report

    Report Number
    0002249697-2022-00990
    Event Type
    Injury
    Date Received
    July 11, 2022
    Date of Event
    September 13, 2021
    Report Date
    October 21, 2022
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    D6A & D6B ADDED. REPORTED EVENT AN EVENT REGARDING INSTABILITY INVOLVING AN UNKNOWN TRIDENT LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS -PRODUCT EVALUATION AND RESULTS: MATERIAL ANALYSIS, VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. -CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. -PRODUCT HISTORY REVIEW: COULD NOT BE PERFORMED AS THE DEVICE LOT DETAILS WERE NOT PROVIDED. -COMPLAINT HISTORY REVIEW: COULD NOT BE PERFORMED AS THE DEVICE LOT DETAILS WERE NOT PROVIDED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS DEVICE IDENTIFICATION AND RETURN, PRE- AND POST-OPERATIVE X-RAYS AND THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    PATIENT HAD INSTABILITY OF THEIR HIP IMPLANTS. LINER EXCHANGED FROM TRIDENT 36D 0DG LINER TO TRIDENT 22.2D CONSTRAINED LINER USING 22.2MM CONSTRAINED IMPACTOR.

    Description of Event or Problem · 0

    PATIENT HAD INSTABILITY OF THEIR HIP IMPLANTS. LINER EXCHANGED FROM TRIDENT 36D 0DG LINER TO TRIDENT 22.2D CONSTRAINED LINER USING 22.2MM CONSTRAINED IMPACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2397281 UNKNOWN_TRIDENT 36D 0DG LINER PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R