BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SIZE 3 PKA INSERT

    MDR report key: 13264633 · Received January 17, 2022

    Report

    Report Number
    3005985723-2022-00008
    Event Type
    Injury
    Date Received
    January 17, 2022
    Date of Event
    March 22, 2021
    Report Date
    May 5, 2022
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: MCK FEMORAL-RM-LL-SZ 3; 180513; UNK. MCK TIBIAL BASEPLATE-RM-LL-SZ 3; 180613; UNK. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. REPORTED EVENT: AN EVENT REGARDING PAIN INVOLVING A MAKO INSERT 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: IT WAS REPORTED THAT THE PATIENT'S KNEE WAS REVISED DUE TO PAIN. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS RETURN OF THE DEVICE, PATHOLOGY REPORTS, 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

    PRE OP DIAGNOSIS: PAINFUL RIGHT MEDIAL UNICONDYLAR KNEE ARTHROPLASTY. POST OP DIAGNOSIS: SAME, RIGHT KNEE PRIMARY OSTEOARTHRITIS PATELLOFEMORAL AND LATERAL COMPARTMENTS. PROCEDURE: REVISION RIGHT TKA. FINDINGS: EXPOSED BONE PF JOINT AND LATERAL FEMORAL CONDYLE, MEDIAL UKA.

    Description of Event or Problem · 0

    PRE OP DIAGNOSIS: PAINFUL RIGHT MEDIAL UNICONDYLAR KNEE ARTHROPLASTY. POST OP DIAGNOSIS: SAME, RIGHT KNEE PRIMARY OSTEOARTHRITIS PATELLOFEMORAL AND LATERAL COMPARTMENTS. PROCEDURE: REVISION RIGHT TKA. FINDINGS: EXPOSED BONE PF JOINT AND LATERAL FEMORAL CONDYLE, MEDIAL UKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019361 UNKNOWN_SIZE 3 PKA INSERT PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention| H