BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN KNEE TIBIAL SLEEVE

    MDR report key: 23003015 · Received September 9, 2025

    Report

    Report Number
    1818910-2025-15453
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NJL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE.

    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. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT. THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: TITLE: COMPARISON OF TOTAL KNEE REVISION WITH TWO PROSTHETIC COMBINATIONS AUTHOR: SUN BO, CAO YAO-WEI, KI KE-WEI, HOU YING-ZHOU, WANG SHAO-HUA, WANG JIN-LIANG CITATION: NOT AVAILABLE. (NO PUBMED CITATION PROVIDED) OBJECTIVE/METHODS/STUDY DATA: THIS STUDY COMPARES THE CLINICAL EFFICACY OF TOTAL KNEE REVISION (TKR) USING SLEEVE SYSTEM VERSUS CONSTRAINED CONDYLAR KNEE (CCK) COMBINED WITH AUGMENT. BETWEEN MARCH 2017 TO NOVEMBER 2020, A TOTAL OF 53 PATIENTS WERE DIVIDED INTO SLEEVE GROUP (N = 22) WHO UNDERWENT TKR USING SLEEVE (DEPUY) COMBINED WITH JOHNSON & JOHNSON REVISION SYSTEM TC3 OR MBT, AND CONDYLAR RESTRICTIVE PROSTHESIS (CCK) GROUP WHO WERE TREATED WITH CKK COMBINED WITH AUGMENT (N = 31). THE FOLLOW-UP TIME RANGED FROM 21 TO 52 MONTHS, WITH AN AVERAGE OF (36.0 ± 3.5) MONTHS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SLEEVE (DEPUY) COMBINED WITH JOHNSON & JOHNSON REVISION SYSTEM TC3 OR MBT ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE CONSTRUCT (QTY:4) - 1 CASE IN SLEEVE GROUP HAD INTRAOPERATIVE PERIPROSTHETIC FRACTURE ¿ DID NOT REQUIRE SURGICAL FIXATION AND WERE PROTECTED WITH A BRACE - 2 CASES HAD DISTAL PROSTHESIS PAIN ¿ NO TREATMENT REPORTED - 1 CASE HAD PERIPROSTHETIC INFECTION ¿ CONTROLLED AFTER DEBRIDEMENT OF RETAINED PROSTHESIS ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE CONSTRUCT (QTY: 1) - 1 CASE (75-YEAR-OLD FEMALE) IN SLEEVE GROUP HAD INTRAOPERATIVE PERIPROSTHETIC FRACTURE ¿ DID NOT REQUIRE SURGICAL FIXATION AND WERE PROTECTED WITH A BRACE ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE TIBIAL SLEEVE AND UNKNOWN KNEE TIBIAL STEM (QTY: 1) - 1 CASE HAD DISPLACEMENT OF SLEEVE COMBINED WITH TIBIAL BIOTYPE STEM ¿ DID NOT REQUIRE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2465876 UNKNOWN KNEE TIBIAL SLEEVE KNEE IMPLANT TIBIAL SLEEVE NJL DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention