BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREE PEG PATELLA 35MM

    MDR report key: 13404831 · Received January 31, 2022

    Report

    Report Number
    1038671-2022-00095
    Event Type
    Injury
    Date Received
    January 31, 2022
    Date of Event
    January 11, 2022
    Report Date
    August 4, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039606
    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

    CONCOMITANT MEDICAL PRODUCTS: LGC FEMORAL PS CEM LEFT SZ 2.5 (CAT# 02-010-01-0225 / SERIAL# (B)(4)); LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 9MM (CAT# 02-012-44-2509 / SERIAL# (B)(4)). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED. (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF LOOSENING OF THE PATELLA COMPONENT, WHICH CREATED A ¿HOT SPOT¿ UNDER THE PATELLA. HOWEVER, THE CAUSE OF THE LOOSENING CANNOT BE DETERMINED BECAUSE THE COMPONENT WAS NOT RETURNED FOR EVALUATION AND NO IMAGES OR X-RAYS WERE PROVIDED. THE MOST PROBABLE ROOT CAUSE ASSOCIATED WITH THE REPORTED EVENT OF "LOOSENING¿ IS ASSOCIATED WITH WEAKENED INTEGRATION OF THE DEVICE AT THE BONE-IMPLANT INTERFACE DUE TO LOSS OF FIBROUS AND/OR BONY TISSUE AND LEADING TO COMPROMISED ANCHORAGE OF THE DEVICE.

    Description of Event or Problem · 0

    AS REPORTED, PATIENT HAD A REVISION DUE TO HOT SPOT UNDER PATELLA. PATIENT¿S PATELLA AND INSERT WERE REVISED DUE TO LOOSENING. THERE WAS NO BREAKAGE OF THE DEVICE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO DEVICES WERE DISPOSED BY HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1640291 THREE PEG PATELLA 35MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. THREE PEG PATELLA 35MM UNK 10885862039606

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention