BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK PATELLOFEMORAL-L-SZ 4

    MDR report key: 10390468 · Received August 11, 2020

    Report

    Report Number
    3005985723-2020-00247
    Event Type
    Injury
    Date Received
    August 11, 2020
    Date of Event
    July 17, 2020
    Report Date
    October 8, 2020
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    NPJ
    UDI-DI
    00848486000424
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING PATIENT FACTORS INVOLVING A MAKO PATELLA WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS PRODUCT WAS NOT RETURNED. -CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. -DEVICE HISTORY REVIEW: COULD NOT BE PERFORMED AS LOT CODE INFORMATION WAS NOT PROVIDED. -COMPLAINT HISTORY REVIEW: COULD NOT BE PERFORMED AS LOT CODE INFORMATION WAS NOT PROVIDED. CONCLUSION: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION INCLUDING DEVICE DETAILS, OPERATIVE REPORTS, PROGRESS NOTES, X-RAYS AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE OR THE PRODUCT IS RETURNED, THIS INVESTIGATION WILL BE RE-OPENED. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. INITIAL PATIENT COMPLAINT WAS PAIN, SURGEON REPORTED THAT THERE ARE NO ALLEGATIONS AGAINST THE IMPLANTS AND THAT PROGRESSION OF THE PATIENT'S EXISTING DISEASE, CAUSING THE KNEE TO COLLAPSE INTO VALGUS. A PATELLOFEMORAL IMPLANT AND PATELLAR COMPONENT WERE REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

    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. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: PATELLAR COMPONENT; UNK_OFL; UNKNOWN. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. INITIAL PATIENT COMPLAINT WAS PAIN, SURGEON REPORTED THAT THERE ARE NO ALLEGATIONS AGAINST THE IMPLANTS AND THAT PROGRESSION OF THE PATIENT'S EXISTING DISEASE, CAUSING THE KNEE TO COLLAPSE INTO VALGUS. A PATELLOFEMORAL IMPLANT AND PATELLAR COMPONENT WERE REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854438 MCK PATELLOFEMORAL-L-SZ 4 PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ STRYKER ORTHOPAEDICS-MAHWAH 180404 UNKNOWN 00848486000424

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R