BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE FEMORAL STEM

    MDR report key: 15377302 · Received September 8, 2022

    Report

    Report Number
    1818910-2022-17352
    Event Type
    Injury
    Date Received
    September 8, 2022
    Date of Event
    July 16, 2022
    Report Date
    September 8, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NJL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THIS COMPLAINT WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. FOLLOW-UPS WERE DONE TO TRY AND OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE JOURNAL ARTICLE. NO FURTHER INFORMATION WAS RECEIVED. THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: LAZIC I, POHLIG F, HAUG AT, SUREN C, LANGER S, PRODINGER PM. MODULAR AUGMENTATION IN VARUS-VALGUS-CONSTRAINED KNEE ARTHROPLASTY-DO WE NEED SLEEVES TO AVOID FEMORAL LOOSENING AFTER EXCESSIVE DISTAL AUGMENTATION? J ARTHROPLASTY. 2022 JUL 16:S0883-5403(22)00693-3. DOI: 10.1016/J.ARTH.2022.07.004. EPUB AHEAD OF PRINT. PMID: 35843377. OBJECTIVE AND METHODS: IN REVISION TOTAL KNEE ARTHROPLASTY, ZONAL FIXATION METHODS WITH A COMBINATION OF AUGMENTS, PRESS-FIT STEMS, AND SLEEVES ARE POPULAR. THE AUTHORS HYPOTHESIZED THAT HIGH DISTAL FEMORAL AUGMENTATION WITH DIAPHYSEAL PRESS-FIT STEMS LEADS TO AN INCREASED RATE OF EARLY ASEPTIC LOOSENING AND THAT FEMORAL METAPHYSEAL SLEEVES IMPROVE IMPLANT SURVIVAL. THE PURPOSE OF THIS STUDY IS TO COMPARE THE RATES OF POSTOPERATIVE ASEPTIC LOOSENING IN TC3 REVISION FEMORAL CONSTRUCTS UTILIZING DISTAL FEMORAL AUGMENTATION AND/OR METAPHYSEAL SLEEVES COMBINED WITH PRESS-FIT FEMORAL STEMS IN 136 KNEES THAT WERE REVISED BETWEEN JANUARY 2012 AND JULY 2018. THE MANUFACTURERS OF THE REVISED IMPLANTS ARE UNKNOWN. THE AUTHORS USED 4, 8, OR 12 MM DISTAL FEMORAL AUGMENTS AND OR FEMORAL METAPHYSEAL SLEEVES COMBINED WITH PRESS-FIT FEMORAL STEMS TO ADDRESS FEMORAL CAVITARY DEFECTS. THE MANUFACTURER OF THE CEMENT UTILIZED TO SECURE THE FEMORAL COMPONENTS, AS WELL AS THE PATELLA AND TIBIAL IMPLANTS ARE UNKNOWN. THIS COMPLAINT CAPTURES THE 13 REVISIONS PERFORMED FOR FEMORAL ASEPTIC LOOSENING AFTER REVISION SURGERY. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: TC3 FEMORAL COMPONENT, 4, 8, OR 12 MM DISTAL FEMORAL SEGMENT, FEMORAL METAPHYSEAL SLEEVE, AND FEMORAL PRESS-FIT STEM. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS ASSOCIATED WITH DEPUY DEVICES: 13 REVISIONS TO TREAT ASEPTIC LOOSENING: 3 CASES INCLUDED METAPHYSEAL SLEEVES, 1 CASE INCLUDED A 4 MM DISTAL FEMORAL AUGMENT, 5 CASES INCLUDED A 12 MM DISTAL FEMORAL AUGMENT, 5CASES INCLUDED AN 8 MM DISTAL FEMORAL AUGMENT, 13 CASES INCLUDED A PRESS-FIT STEM AND FEMORAL COMPONENT REVISION. THE LOOSENING INTERFACE FOR THE FEMORAL COMPONENT AND LOOSENED AUGMENTS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2236940 UNKNOWN KNEE FEMORAL STEM KNEE IMPLANT : FEMORAL STEM NJL DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention