BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS TIBIAL INSERTS SZ 2, 11MM

    MDR report key: 16783990 · Received April 21, 2023

    Report

    Report Number
    1038671-2023-00785
    Event Type
    Injury
    Date Received
    April 21, 2023
    Date of Event
    July 15, 2022
    Report Date
    September 13, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862048233
    PMA / PMN Number
    K933610
    Removal / Correction Number
    Z-0019-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10. ADDITIONAL/UPDATED INFORMATION ¿ B1, B5, B6, B7, D8, H6 HEALTH EFFECT - CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE, H7, & H9. THERE IS NO OTHER INFORMATION AVAILABLE. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION.

    Additional Manufacturer Narrative · 0

    H3: INVESTIGATION RESULTS: THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR AND OSTEOLYSIS. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. IT COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED WHETHER THE REPORTED BACKSIDE WEAR WAS THE RESULT OF INCOMPLETE SEATING OF THE TIBIAL INSERT OR LOOSENING OF THE INSERT WITHIN THE TRAY. THE EXTENT AND ROOT CAUSE OF THE PROSTHESIS WEAR AND OSTEOLYSIS COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6 CLINICAL CODE, PROBLEM CODE. CORRECTION: H6 COMPONENT CODE.

    Description of Event or Problem · 0

    REVISION OPERATIVE OF 15 JUL 2022-PATIENT WAS REVISED TO COMPETITOR¿S DEVICES. PREOPERATIVE DIAGNOSIS: GLOBAL INSTABILITY STATUS POST LEFT TOTAL KNEE REPLACEMENT, RECURRENT EFFUSIONS AND PAIN. PROCEDURE(S): REVISION LEFT TOTAL KNEE REPLACEMENT, BOTH COMPONENTS. FINDINGS: GLOBAL INSTABILITY UNDER ANESTHESIA WITH 5 DEG HYPEREXTENSION, MED/LAT LAXITY IN EXTENSION MID FLEXION AND FLEXION WITH 1 CM AP TRANSLATION. POST WEAR. COMPONENTS WELL FIXED. AORI TYPE I BONE LOSS TIBIA AND TYPE I BONE LOSS FEMUR. NO GROSS EVIDENCE OF INFECTION. LOOSE POLY INSERT WITHIN THE TRAY CONSISTENT WITH BACKSIDE WEAR. PROCEDURE: SYNOVECTOMY WAS PERFORMED. THE PATELLA WAS FOUND TO BE WELL FIXED AND SO WAS RETAINED DUE TO MORBIDITY OF REMOVAL. THE SIZE 11 MM PS POLYETHYLENE INSERT WAS FOUND TO BE LOOSE ON THE TRAY AND THERE WAS SEVERE WEAR OF THE POST. THE FEMORAL COMPONENT WAS FOUND TO BE WELL FIXED; THE COMPONENT WAS THEN REMOVED USING A BONE TAMP WITH MINIMAL BONE LOSS. REMOVAL OF THE FEMORAL COMPONENT REVEALED AORI TYPE I BONE LOSS. THE TIBIAL COMPONENT WAS FOUND TO BE WELL FIXED; THE TIBIAL COMPONENT WAS THEN REMOVED. BONY INVENTORY OF THE TIBIA REVEALED AORI TYPE I BONE LOSS. THERE WAS EXCELLENT SUPPORTIVE BONE FOR TIBIAL COMPONENT AND SO A CONE WAS NOT NEEDED. DEVICES WERE TRAILED AND THEN IMPLANTED. DRESSINGS WERE APPLIED. THERE WERE NO COMPLICATIONS. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. PATIENT DISCHARGED HOME FROM THE HOSPITAL WHEN COMFORTABLE AND HAVE MET ALL PT GOALS. THERE IS NO DEVICE RETURN, THERE ARE NO PROVIDED IMAGES, THERE IS NO OTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY LEGAL, APPROXIMATELY 14 YEARS POST OP THE INITIAL LEFT TKA, THIS FEMALE PATIENT WAS REVISED. REASON FOR REVISION WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685928 PS TIBIAL INSERTS SZ 2, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK UNK 10885862048233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female