BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_KNEE

    MDR report key: 19570479 · Received June 19, 2024

    Report

    Report Number
    0002249697-2024-00905
    Event Type
    Injury
    Date Received
    June 19, 2024
    Date of Event
    May 28, 2024
    Report Date
    June 19, 2024
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING ROM INVOLVING AN UNKNOWN KNEE 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 REMAINS IMPLANTED. 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: 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

    THIS PI IS FOR THE PT'S RIGHT KNEE AND ITS ONGOING ROM ISSUES. IT WAS REPORTED VIA THE STRYKER FACEBOOK HOMEPAGE, "I HAVE BOTH KNEES REPLACED. BOTH BY SAME DR/CLINIC AND ARE STRYKER KNEES AND DONE USING MACO. RIGHT KNEE DONE ON (B)(6) 2018 AND AT LEAST 3 MANUAL MANIPULATIONS AND 6.5 MONTHS OF PHYSICAL THERAPY. LEFT KNEE WAS REPLACED (B)(6) 2019. 1 MANUAL MANIPULATIONS PT ON (B)(6) 2019. THEN LYSIS OF ADHESIONS AND ANOTHER MANUAL MANIPULATIONS (B)(6) 2020. ON (B)(6) 2021 HAD ARTHROTOMY ON LEFT KNEE (OPENING UP OF KNEE AGAIN) AND ANOTHER MANUAL MANIPULATION OF RIGHT KNEE AND MORE PT THROUGH (B)(6) 2022. ON (B)(6) 2022 WENT FOR CHECKUP HAD LOST A LOT OF MOVEMENT IN LEFT KNEE AGAIN. MY OPTIONS WERE MORE PT, ANOTHER TOTAL REPLACEMENT, GET A SECOND OPINION. I DID SOME MORE PT STILL NOT MUCH BETTER. SO I SOUGHT OUT A SECOND OPINION AND WAS FINALLY ABLE TO GET AN APT AT (B)(6) (WELL KNOWN TEACHING HOSPITAL AND CLINICS). OUTCOME - THE BEST WAY TO FIX IS ANOTHER TOTAL KNEE REPLACEMENT. I WASN'T QUIET READY FOR THE PAIN AGAIN. THIS DR SAID SHE DOES HER REPLACEMENTS A LITTLE DIFFERENTLY. MY MOTION IN THE LEFT KNEE IS VERY LIMITED, VERY DIFFICULT TO BEND. IF I'M ON MY FEET TOO LONG I HAVE DIFFICULTY WALKING. THERE ARE TIMES I HAVE TO USE MY CANE. DON'T EVEN HAVE 90 DEGREE BEND. WE WERE ABLE TO GET RIGHT ONE TO 120 BUT IT HAS DIGRESSED TO ABOUT 90."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549244 UNKNOWN_KNEE PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other