BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK PATELLOFEMORAL-L-SZ 5

    MDR report key: 22826562 · Received August 18, 2025

    Report

    Report Number
    3005985723-2025-00378
    Event Type
    Injury
    Date Received
    August 18, 2025
    Date of Event
    January 30, 2025
    Report Date
    September 29, 2025
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: UNKNOWN MCK PATELLA; CAT# UNKNOWN; LOT# UNKNOWN. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING REVISION INVOLVING A MAKO FEMORAL COMPONENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION: THE REPORTED DEVICE WAS NOT RETURNED HOWEVER PHOTOGRAPHS WERE PROVIDED FOR REVIEW. THERE IS NOTHING REMARKABLE TO REPORT FROM REVIEW OF THE PHOTOGRAPHS. NO CONCLUSIVE DECISION CAN BE MADE FROM THE PROVIDED PHOTO. MATERIAL ANALYSIS, FUNCTIONAL, AND DIMENSIONAL INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. CLINICIAN REVIEW: A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED: CONFIRMATION OF EVENT: ASSUMING THAT THE EVENT WAS THE REVISION OF THIS PATELLOFEMORAL REPLACEMENT, I HAVE NO DOCUMENTATION OF INFORMATION THAT COULD CONFIRM REVISION SURGERY. THE REVISION WAS REPORTED IN THE INQUIRY SUMMARY. I CAN CONFIRM THAT I SAW AN UNDATED UNMARKED PHOTOGRAPH OF A PATELLOFEMORAL PROTHESIS WITH A METALLIC TROCCHIA, A POLYETHYLENE PATELLA AND A SCREW. ROOT CAUSE ANALYSIS: THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH CERTAINTY. ASSUMING A REVISION TOOK PLACE THE CAUSES OF REVISION OF A PATELLA, FEMORAL, PROSTHESIS OR MULTIFACTORIAL, INCLUDING SURGICAL TECHNIQUE IN THE WAY IT IS IMPLANTED, ALIGNED, POSITIONED AND FIXED. ANOTHER POSSIBLE CAUSE COULD BE DEGENERATION OF THE OTHER TWO COMPARTMENTS WITH CONTINUED PAIN AND DISABILITY. I WOULD DOUBT CAUSALITY FROM THE PATIENT¿S LIFESTYLE, ACTIVITY LEVEL OR BMI. WITH THE INFORMATION PROVIDED I WOULD NOT ASSIGN ANY CAUSALITY TO THE IMPLANT ITSELF. 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 'RECEIVED IMAGES OF EXPLANTED MCK KNEE PROSTHESES ON PI. A MAKO KNEE REVISION TOOK PLACE FOR UNKNOWN REASONS, DATE UNKNOWN. NO OTHER INFORMATION IS KNOWN AT THIS TIME.' A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED: CONFIRMATION OF EVENT: ASSUMING THAT THE EVENT WAS THE REVISION OF THIS PATELLOFEMORAL REPLACEMENT, I HAVE NO DOCUMENTATION OF INFORMATION THAT COULD CONFIRM REVISION SURGERY. THE REVISION WAS REPORTED IN THE INQUIRY SUMMARY. I CAN CONFIRM THAT I SAW AN UNDATED UNMARKED PHOTOGRAPH OF A PATELLOFEMORAL PROTHESIS WITH A METALLIC TROCCHIA, A POLYETHYLENE PATELLA AND A SCREW. ROOT CAUSE ANALYSIS: THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH CERTAINTY. ASSUMING A REVISION TOOK PLACE THE CAUSES OF REVISION OF A PATELLA, FEMORAL, PROSTHESIS OR MULTIFACTORIAL, INCLUDING SURGICAL TECHNIQUE IN THE WAY IT IS IMPLANTED, ALIGNED, POSITIONED AND FIXED. ANOTHER POSSIBLE CAUSE COULD BE DEGENERATION OF THE OTHER TWO COMPARTMENTS WITH CONTINUED PAIN AND DISABILITY. I WOULD DOUBT CAUSALITY FROM THE PATIENT¿S LIFESTYLE, ACTIVITY LEVEL OR BMI. WITH THE INFORMATION PROVIDED I WOULD NOT ASSIGN ANY CAUSALITY TO THE IMPLANT ITSELF. 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 REVISION 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

    THE FOLLOWING WAS REPORTED: "A MAKO KNEE REVISION TOOK PLACE FOR UNKNOWN REASONS, DATE UNKNOWN. NO OTHER INFORMATION IS KNOWN AT THIS TIME."

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1680031 MCK PATELLOFEMORAL-L-SZ 5 PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. 26051010

    Patients

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