BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL KNEE SOLUTION

    MDR report key: 20126770 · Received August 30, 2024

    Report

    Report Number
    MW5159163
    Event Type
    Injury
    Date Received
    August 30, 2024
    Date of Event
    November 1, 2021
    Report Date
    November 20, 2024
    Manufacturer
    ORTHO DEVELOPMENT CORP.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2021, I HAD AN ORTHO DEVELOPMENT LEFT TOTAL KNEE REPLACEMENT IN (B)(6), VIA (B)(6). I WAS DISCHARGED THE SAME DAY WITH AN EMESIS BAG. PER MY TRANSPORTATION/FAMILY MEMBER, "THE ENTIRE KNEE REPLACEMENT TOOK 20 MINUTES AND YOU WERE IN RECOVERY¿. I HAVE NOT HAD A PAIN-FREE DAY SINCE (B)(6) 2021. ON (B)(6) 2022, I HAD A MANIPULATION (¿MAU") TO THE REPLACEMENT. BOTH WERE PERFORMED IN (B)(6). ON (B)(6) 2022 VIA AN IMAGING REPORT, THE IMPRESSION STATED: A LINEAR FOCUS OF HYPOINTENSE T1 AND T2 SIGNAL IS SEEN EXTENDING FROM THE FEMORAL PROSTHESIS CRANIALLY INTO THE IMAGED SEGMENT OF THE FEMORAL SHAFT WITH MILD SURROUNDING MARROW EDEMA-LIKE SIGNAL SUSPICIOUS FOR A NONDISPLACED PERIPROSTHETIC FRACTURE. ON (B)(6) 2023, VIA AN IMAGING REPORT, THE IMPRESSION STATED: THREE-PHASE BONE IMAGING STUDY WITH ATTENTION TO THE KNEES SHOWS INCREASED ACTIVITY AROUND THE LEFT FEMORAL AND TIBIAL COMPONENTS ON ALL 3 PHASES IS SUGGESTIVE OF HARDWARE LOOSENING. (ORDERED BY (B)(6)). ON (B)(6) 2024, VIA AN IMAGING REPORT THE IMPRESSION STATED: THREE-PHASE BONE IMAGING STUDY WITH ATTENTION TO THE LEFT KNEE SHOWS: 1. STABLE ABNORMAL INCREASED ACTIVITY AROUND THE LEFT FEMORAL AND TIBIAL COMPONENTS OF THE KNEE REPLACEMENT SUGGESTION OF STABLE HARDWARE LOOSENING. 2. NEW SUBTLE, SMALL FOCUS OF UPTAKE IN THE LEFT PROXIMAL FEMORAL SHAFT ON ALL PHASES IS SUSPICIOUS FOR A STRESS FRACTURE (ORDERED BY (B)(6)). ON (B)(6) 2024, I WAS SEEN BY (B)(6), (B)(6) HOSPITAL. PER DR. (B)(6): "PATIENT HAS PAINFUL LEFT TOTAL KNEE. THIS APPEARS TO BE THE RESULT OF LOOSENING. SHE MOST LIKELY WOULD BENEFIT FROM REVISION. I AM CONCERNED THERE COULD BE AN UNDIAGNOSED INFECTION. IF NECESSARY, I WOULD ASPIRATE THE KNEE BEFORE PROCEEDING TO [A] REVISION. SHE HAS BEEN HAVING SOME THIGH PAIN AFTER SHE INCREASED HER [PT] ACTIVITY AND THERE IS EVIDENCE OF A STRESS FRACTURE". PER ORIGINAL TOTAL KNEE SURGEON¿S ASSISTANT ON (B)(6) 2023, "DR. (B)(6) SUGGESTS THAT YOU PROBABLY FIND A DOCTOR AND PROCEED WITH A REVISION". ON (B)(6) 2022, (B)(6), UNABLE TO HELP/TREAT. ON (B)(6) 2022, (B)(6) - NOT INTERESTED IN FURTHER TREATMENT; (B)(6) 2022 (B)(6) - UNABLE TO HELP/FURTHER TREAT. ON (B)(6) 2023, DR. (B)(6) - UNABLE- TO HELP/FURTHER TREAT. ON (B)(6) 2023, DR. (B)(6), (B)(6) HOSPITAL - INTERVENTIONAL RADIOLOGIST - UNABLE TO HELP/FURTHER TREAT. ON (B)(6) 2023, DR. (B)(6) - UNABLE TO HELP/TREAT. ON (B)(6) 2024, DR. (B)(6) - NOT INTERESTED IN FURTHER TREATMENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 11/20/2024 FOR REPORT MW5159163. I THANK YOU FOR YOUR TIME MOMENTS AGO, IN ASSISTING. AS MENTIONED, I WOULD LIKE TO ADD THE OP NOTE TO ACCESS NUMBER: MW5159163. THIS, AS THE DEVICE DID NOT LAST MORE THAN A FEW MONTHS, PRIOR TO LOOSENING. AGAIN, I AM A NOVICE IN THIS AREA; THUS, I DO NOT KNOW IF THE LOOSENING WAS DUE TO THE ORTHO DEV DEVICE, THE CEMENT, OR 'USER ERROR.' IN ADVANCE, I THANK YOU FOR YOUR TIME AND ATTENTION TO THE ABOVE-REFERENCED MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1056222 TOTAL KNEE SOLUTION PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH ORTHO DEVELOPMENT CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Other| S| R ALBUTEROL SULFATE.| AMLODIPINE 2.5.| ARFORMOTEROL.| CETIRIZINE 10 MG.| ELDERBERRY.| FLUTICASONE PROPIONATE.| LEVOTHYROXINE 75 MG.| LIOTHYRONINE 5 MG.| MONTELUKAST 10 MG.| ROSUVASTATIN 5 MG.| VITAMIN B12.| VITAMIN C.| ZINC.