BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMP RP INSERT STD 10MM

    MDR report key: 23630383 · Received November 24, 2025

    Report

    Report Number
    1818910-2025-20611
    Event Type
    Injury
    Date Received
    November 24, 2025
    Date of Event
    February 17, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NJL
    UDI-DI
    10603295022015
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    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. 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.

    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 MANUFACTURER 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). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: ADDED: D4 (LOT, CATALOG, EXPIRY DATE), G4 ( PMA/ 510(K)), H4. CORRECTED: D1, D2A, D4 (PRIMARY UDI NUMBER). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT 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: SCHOUTENS C, NOLTE PA, VAN NOORT A. TRAUMATIC ANTERIOR TIBIOFEMORAL DISLOCATION OF MOBILE-BEARING TOTAL KNEE ARTHROPLASTY: TWO CASES. TRAUMA CASE REP. 2025 FEB 17;56:101144. DOI: 10.1016/J.TCR.2025.101144. PMID: 40083388; PMCID: PMC11904596. OBJECTIVE/METHODS/STUDY DATA: THIS STUDY PRESENTS 2 CASES; CASE 1: A 71-YEAR-OLD CAUCASIAN WOMAN PRESENTED TO THE EMERGENCY DEPARTMENT AFTER A FALL FROM STANCE ONTO THE FLOOR IN THE DOMESTIC SETTING, IN WHICH HYPEREXTENSION OF HER LEFT PROSTHETIC KNEE JOINT HAD PROBABLY OCCURRED. A LCS COMPLETE¿ CEMENTLESS ROTATING PLATFORM TKA HAD BEEN IMPLANTED FIFTEEN YEARS PRIOR FOR SYMPTOMATIC LATERAL OSTEOARTHRITIS. CASE 2: A 73-YEAR-OLD CAUCASIAN WOMAN PRESENTED TO THE EMERGENCY ROOM AFTER SLIPPING ON AN OIL SPILL AND FALLING DIRECTLY ONTO HER LEFT KNEE. SHE WAS IN SEVERE PAIN, COULD NOT BEAR WEIGHT, AND HAD A DEFORMED LEFT KNEE JOINT. A LEFT LSC COMPLETE¿ CEMENTLESS ROTATING PLATFORM TKA HAD BEEN IMPLANTED 8 YEARS PRIOR FOR SYMPTOMATIC OSTEOARTHRITIS IN AN UNCOMPLICATED PROCEDURE. LOT, MODEL AND CATALOG NUMBERS ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: LCS COMPLETE¿ ROTATING PLATFORM CEMENTLESS; DEPUY, WARSAW, IN). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE FEMORAL LCS (QTY: 1) IP-02571802: 71-YEAR-OLD CAUCASIAN WOMAN: PAIN, WALKING DIFFICULTY, SURGICAL INTERVENTION, JOINT DISLOCATION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE TIBIAL INSERT LCS (QTY:1) IP-02571803: 71-YEAR-OLD CAUCASIAN WOMAN: PAIN, WALKING DIFFICULTY, SURGICAL INTERVENTION, JOINT DISLOCATION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE FEMORAL LCS (QTY: 1) IP-02571804: 73-YEAR-OLD CAUCASIAN WOMAN: PAIN, SWELLING, WALKING DIFFICULTY, SURGICAL INTERVENTION, DEVICE REVISION OR REPLACEMENT, SOFT TISSUE INJURY, JOINT INSTABILITY. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE TIBIAL INSERT LCS (QTY: 1) IP-02573334: 73-YEAR-OLD CAUCASIAN WOMAN: PAIN, SWELLING, WALKING DIFFICULTY, SURGICAL INTERVENTION, DEVICE REVISION OR REPLACEMENT, SOFT TISSUE INJURY, AND JOINT INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2307138 LCS COMP RP INSERT STD 10MM KNEE TIBIAL INSERT NJL DEPUY ORTHOPAEDICS INC US 550834 10603295022015

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention