BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORATION ADM X3 INS

    MDR report key: 19669891 · Received July 3, 2024

    Report

    Report Number
    0002249697-2024-00964
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    June 12, 2024
    Report Date
    November 5, 2024
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    UDI-DI
    04546540665881
    PMA / PMN Number
    K103233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. 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

    REPORTED EVENT: AN EVENT REGARDING DISASSOCIATION INVOLVING AN MDM 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: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. 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

    ON (B)(6) 2024, PRIMARY SURGERY WAS PERFORMED AND THE DEVICES WERE IMPLANTED IN THE LEFT HIP. DISLOCATION BETWEEN THE METAL HEAD AND THE POLYETHYLENE INSERT.

    Description of Event or Problem · 0

    ON (B)(6) 2024, PRIMARY SURGERY WAS PERFORMED AND THE DEVICES WERE IMPLANTED IN THE LEFT HIP. DISLOCATION BETWEEN THE METAL HEAD AND THE POLYETHYLENE INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467170 RESTORATION ADM X3 INS PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC MEH STRYKER ORTHOPAEDICS-MAHWAH 91369201 04546540665881

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H