BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEOS

    MDR report key: 15298664 · Received August 25, 2022

    Report

    Report Number
    3013450937-2022-00226
    Event Type
    Injury
    Date Received
    August 25, 2022
    Date of Event
    July 26, 2022
    Report Date
    November 23, 2022
    Manufacturer
    ONKOS SURGICAL
    Product Code
    KRO
    UDI-DI
    B278KTAGB210E0
    PMA / PMN Number
    K161520
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS IN PROGRESS. WHEN IT IS COMPLETE A SUPPLEMENTAL MDR WILL BE SUBMITTED ACCORDINGLY. MULITPLE MDRS WERE SUBMITTED FOR THIS ADVERSE EVENT: 3013450937-2022-00220, 3013450937-2022-00221, 3013450937-2022-00222, 3013450937-2022-00223, 3013450937-2022-00224, 3013450937-2022-00225 AND 3013450937-2022-00227.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO INCLUDE ADDITIONAL INFORMATION. THE INVESTIGATION IS COMPLETE. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE ALLEGED INFECTION COULD NOT BE DETERMINED. ON 24 OCT 2022, WHEN COMPLETING THE INVESTIGATION, IT WAS IDENTIFIED THAT TWO OF THE INITIAL MDRS THAT WERE SUBMITTED DID NOT SUCCESSFULLY GO THROUGH AS THEY WERE ASSIGNED DUPLICATE MFR NUMBERS. 3013450937-2022-00349 AND 3013450937-2022-00348 WERE SUBMITTED FOR THESE PARTS. MULTIPLE MDRS WERE SUBMITTED FOR THIS ADVERSE EVENT: 3013450937-2022-00348, 3013450937-2022-0000349, 3013450937-2022-00222, 3013450937-2022-00223, 3013450937-2022-00224, 3013450937-2022-00225 AND 3013450937-2022-00227. THE FOLLOWING SECTIONS WERE UPDATED: H3: DEVICE EVALUATED BY MANUFACTURER UPDATED TO NO. H6: TYPE OF INVESTIGATION CODE UPDATED TO 4110: TREND ANALYSIS. H6: TYPE OF INVESTIGATION CODE UPDATED TO 4117: DEVICE NOT ACCESSIBLE FOR TESTING. H6: INVESTIGATION FINDINGS CODE UPDATED TO 3221: NO FINDINGS AVAILABLE. H6: INVESTIGATION CONCLUSIONS CODE UPDATED TO 4315: CAUSE NOT ESTABLISHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED AN INFECTION AND UNDERWENT A REVISION SURGERY. THE FOLLOWING IMPLANTS WERE REMOVED DURING THE REVISION: ELEOS DISTAL FEMUR AXIAL PIN, ELEOS TIBIAL BASEPLATE, ELEOS TIBIAL POLY SPACER, ELEOS TIBIAL HINGE W/ ROTATIONAL STOP, ELEOS STEM EXTENSION, ELEOS DISTAL FEMUR, ELEOS TIBIAL BLOCK AUGMENT AND ELEOS CEMENTED SEGMENTAL STEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED AN INFECTION AND UNDERWENT A REVISION SURGERY. THE FOLLOWING IMPLANTS WERE REMOVED DURING THE REVISION: ELEOS DISTAL FEMUR AXIAL PIN, ELEOS TIBIAL BASEPLATE, ELEOS TIBIAL POLY SPACER, ELEOS TIBIAL HINGE W/ ROTATIONAL STOP, ELEOS STEM EXTENSION, ELEOS DISTAL FEMUR, ELEOS TIBIAL BLOCK AUGMENT AND ELEOS CEMENTED SEGMENTAL STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384388 ELEOS TIBIAL BLOCK AUGMENT SIZE: 2 THICKNESS: 10MM KRO ONKOS SURGICAL KTAGB210E 1719298 B278KTAGB210E0

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Hospitalization| R 25000009E ELEOS DISTAL FEMUR SIZE:RIGHT, SEGMENTAL.| 25001208E ELEOS TIBIAL POLY SPACER THICKNESS: 8MM.| 25002111E ELEOS DISTAL FEMUR AXIAL PIN.| CS-13120-03M ELEOS CEMENTED SEGMENTAL STEM.| KSP10100E ELEOS STEM EXTENSION, CANAL FILLING.| TB-2202E-01M ELEOS SIZE 2 TIBIAL BASEPLATE.| THSMWRS01M ELEOS TIBIAL HINGE W/ROTATIONAL STOP.