BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREE PEG PATELLA 38MM

    MDR report key: 20359771 · Received October 3, 2024

    Report

    Report Number
    1038671-2024-03812
    Event Type
    Injury
    Date Received
    October 3, 2024
    Date of Event
    September 19, 2024
    Report Date
    December 26, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039613
    PMA / PMN Number
    K932690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 264-22-11, RBK PS TIBIAL INSERT SZ 2, 11MM, (B)(6). 264-22-09, RBK PS TIBIAL INSERT SZ 2, 09MM, (B)(6). 260-04-23, RBK CEM FIN TIB TRAY SZ 2F/3T, (B)(6). 244-02-02, OPTETRAK ASY HI-FLEX PS CEM FEM, SZ 2, LEFT, (B)(6). 260-04-22, RBK CEM FIN TIB TRAY SZ 2F/2T, (B)(6). 244-03-02, OPTETRAK ASY HI-FLEX PS CEM FEM, SZ 2, RIGHT, (B)(6). 203-90-10, (2617) PWRPRO/VERSIPOWER 90X13MM .050 1.27MM, (B)(6). 203-90-22, (3118) HALL PWR PRO/VERS PWR PLUS 90X19X1.19MM, (B)(6). 203-90-10, (2617) PWRPRO/VERSIPOWER 90X13MM .050 1.27MM, (B)(6). 203-90-01, 11-2624 POWERPRO SAWBLADE, (B)(6). 203-90-01, 11-2624 POWERPRO SAWBLADE, (B)(6).

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D4-EXPIRATION DATE. D8. H4- MANUFACTURE DATE. H6. THE FOLLOWING SECTIONS WERE CORRECTED: B2. D4- SERIAL NUMBER. THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR AND FRACTURE WHICH MAY HAVE BEEN DUE TO ORIENTATION OF THE COMPONENTS, JOINT INSTABILITY, THIRD BODY WEAR, PATIENT RELATED CONDITIONS, OR ANY COMBINATION OF THESE POSSIBILITIES. HOWEVER, THIS CANNOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS OF USER OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO RADIOGRAPHS OR RELEVANT CLINICAL INFORMATION WAS PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 6 YEARS AND 9 MONTHS POST THE INITIAL BILATERAL TOTAL KNEE ARTHROPLASTY (TKA), THE PATIENT UNDERWENT A BILATERAL POLY EXCHANGE DUE TO PAIN IN THE KNEES. SUSPECTED DUE TO POLY WEAR/LYSIS. POLY IN BOTH KNEES WERE EXCHANGED TO EXACTECH IMPLANTS, BOTH PATELLA'S WERE EXCHANGED TO COMPETITOR DEVICES. THE PEG UNDERNEATH THE LINER WAS BROKEN WHILE BEING REMOVED. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870100 THREE PEG PATELLA 38MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862039613

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H11