BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE TIBIAL SLEEVE

    MDR report key: 15063815 · Received July 20, 2022

    Report

    Report Number
    1818910-2022-13452
    Event Type
    Injury
    Date Received
    July 20, 2022
    Date of Event
    February 25, 2022
    Report Date
    July 20, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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.

    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. DEVICE HISTORY LOT : A MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: VAN RENSCH PJH, HEESTERBEEK PJC, VAN LOON CJ. TIBIAL METAPHYSEAL SLEEVES IN PRIMARY TOTAL KNEE ARTHROPLASTY FOLLOWING HIGH TIBIAL OSTEOTOMY AND TIBIAL PLATEAU FRACTURE; PRELIMINARY MID-TERM SURVIVAL AND OUTCOME. KNEE. 2022 MAR;35:98-104. DOI: 10.1016/J.KNEE.2022.02.012. EPUB 2022 MAR 8. PMID: 35276553. OBJECTIVE AND METHODS: AUTHORS INVESTIGATE THE SHORT-TO-MIDTERM CLINICAL AND RADIOGRAPHIC RESULTS OF USING A METAPHYSEAL SLEEVE IN CONJUNCTION WITH A STEMMED TIBIAL REVISION TRAY TO ADDRESS PRIMARY TOTAL KNEE ARTHROPLASTY FOR PATIENTS WITH A HISTORY OF HIGH TIBIAL OSTEOTOMY (HTO) OR TIBIAL PLATEAU FRACTURE (TPF). THESE TWO PRESENTING CONDITIONS HISTORICALLY RESULT IN HIGHER INSTANCES OF IMPLANT LOOSENING DUE TO THE ALTERED METAPHYSEAL BONE STRUCTURE IN STANDARD TOTAL KNEE ARTHROPLASTIES. 28 PATIENTS (11 FROM HTO GROUP, AND 17 FROM TPF GROUP) WERE ASSESSED FOR TWO YEARS, WITH REGULAR FOLLOW-UPS TO DETERMINE PRE-AND POST-PROCEDURE PAIN, SATISFACTION AND GENERAL HEALTH SCORES, POST-OPERATIVE RADIOGRAPHS TO ASCERTAIN RADIOLUCENCY LINES, AND REVISION WITH REMOVAL OF PRIMARY PROSTHESIS FOR ANY REASON BEING THE ENDPOINT. J&J LCS TOTAL KNEE PROSTHESIS WERE USED WITH A STEMMED REVISION TRAY AND METAPHYSEAL SLEEVE. PATELLAS WERE NOT RESURFACED AT PRIMARY. CEMENT MANUFACTURER WAS NOT PROVIDED. RESULTS: THERE WERE NO CASES OF ASEPTIC LOOSENING AT NINE YEARS FOLLOW-UP. 2 PATIENTS DIED DURING THE FOLLOW-UP PERIOD FOR UNRELATED CAUSES. THERE WERE 7 REPORTED COMPLICATIONS: 2: ARTHROFIBROSIS (ONE TREATED WITH MANIPULATION UNDER ANESTHESIA); 1: INFECTION (REQUIRING 2 STAGE REVISION¿EXPLANTATION W/ANTIBIOTIC SPACER; RE-IMPLANTATION); 1: INFECTION (REQUIRING DEBRIDEMENT WITH RETENTION OF PROSTHESIS); 2: PAIN, PATELLAR (ONE WAS TREATED WITH PATELLAR RESURFACING); 1: INSTABILITY, MEDIAL, MILD (TREATED WITH AN ORTHOPEDIC BRACE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829762 UNKNOWN KNEE TIBIAL SLEEVE KNEE TIBIAL SLEEVE JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention