BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0 RIO ROBOTIC ARM - MICS

    MDR report key: 10055924 · Received May 14, 2020

    Report

    Report Number
    3005985723-2020-00200
    Event Type
    Injury
    Date Received
    May 14, 2020
    Date of Event
    May 8, 2020
    Report Date
    September 21, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030407
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED, "REVISED FEMUR OF UNI PKA. CASE TYPE:PKA (MICS)¿. IT WAS ALSO NOTED IN THE COMMUNICATION LOG: CEMENT MANTLE WAS LOOSE, FEMUR HAD CEMENT BUT CEMENT DIDN'T INTERDIGITATE TO BONE, THIS CASE WAS A REVISION OF A PREVIOUS PARTIAL KNEE MAKO CASE. PRODUCT EVALUATION AND RESULTS: REVIEW OF THE CASE SESSION FILES WAS NOT PERFORMED AS CASE SESSION DATA WAS NOT PROVIDED. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS ASSOCIATED WITH (B)(6) INDICATE THAT ON 10 SEPTEMBER 2019 QUALITY INSPECTION PROCEDURES WERE COMPLETED WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: A SEARCH OF THE COMPLAINT DATABASE UNDER DEVICE IDENTIFICATION PN 219999 REPORTS SIMILAR COMPLAINTS FOR PKA SOFTWARE ¿ OTHER. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS RETURN OF THE CASE SESSION DATA, PRE AND POST-OPERATIVE X-RAYS, AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    REVISED FEMUR OF UNI PKA. CASE TYPE:PKA (MICS).

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REVISED FEMUR OF UNI PKA. CASE TYPE: PKA (MICS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522847 3.0 RIO ROBOTIC ARM - MICS ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. 209999 00848486030407

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| O| R