BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK PATELLOFEMORAL-L-SZ 4

    MDR report key: 19170833 · Received April 24, 2024

    Report

    Report Number
    3005985723-2024-00050
    Event Type
    Injury
    Date Received
    April 24, 2024
    Date of Event
    January 2, 2024
    Report Date
    April 24, 2024
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    UDI-DI
    00848486000424
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING WEAR INVOLVING A MAKO PATELLA WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS:  DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION: THE DEVICE WAS NOT RETURNED; HOWEVER, PHOTOGRAPHS WERE PROVIDED FOR REVIEW. THE PHOTOS SHOW A RECENTLY EXPLANTED INSERT WITH SIGNS OF WEAR. CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. DEVICE 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. CONCLUSION: IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. THE DEVICE WAS NOT RETURNED; HOWEVER, PHOTOGRAPHS WERE PROVIDED FOR REVIEW. THE PHOTOS SHOW A RECENTLY EXPLANTED PATELLA WITH SIGNS OF WEAR. A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED: "VERY LITTLE CLINICAL INFORMATION WAS PROVIDED FOR REVIEW. NO PREOPERATIVE OR POSTOPERATIVE RECORDS WERE PROVIDED. NO PREOPERATIVE OR POSTOPERATIVE RADIOGRAPHS WERE PROVIDED. THE PI EVENT REPORTS A REVISION OF A BICONDYLAR MAKO KNEE REPLACEMENT (MEDIAL AND PATELLA-FEMORAL). THE REASON FOR REVISION WAS STATED AS LATERAL KNEE PAIN. X-RAYS DO NOT SHOW SIGNIFICANT LATERAL JOINT PATHOLOGY, BUT A FLEXION VIEW WAS NOT PROVIDED FOR REVIEW. THE PREOPERATIVE EVALUATION, INTRAOPERATIVE FINDINGS AND OUTCOME OF THE SURGERY WERE NOT PROVIDED FOR REVIEW. EVENT CONFIRMATION: THE EVENT, A REVISION KNEE SURGERY, CANNOT BE CONFIRMED WITHOUT ADDITIONAL MEDICAL INFORMATION. ROOT CAUSE: THE ROOT CAUSE OF THE REVISION WAS STATED AS LATERAL JOINT PAIN. THE EVENT WAS NOT CONFIRMED THUS A ROOT CAUSE CANNOT BE ASCERTAINED." NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    LEFT KNEE REVISION DONE TODAY. ON (B)(6) 2024), THE REVISION TODAY WAS DUE TO LATERAL JOINT PAIN IN THE KNEE. NO INFORMATION IS AVAILABLE FROM THE PRIMARY SURGERY FOR THIS PATIENT. NO FURTHER INFORMATION AVAILABLE FROM THE DOCTOR OR HOSPITAL. APR 18, 2024: INVESTIGATION OF DEVICE IMAGES SHOWED WEAR ON BOTH THE TIBIAL INSERT AND THE PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083549 MCK PATELLOFEMORAL-L-SZ 4 PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. 26190412-01 00848486000424

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Hospitalization| R