BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURALOC CONST LINER 54X32

    MDR report key: 21403112 · Received February 18, 2025

    Report

    Report Number
    1818910-2025-02662
    Event Type
    Injury
    Date Received
    February 18, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWZ
    UDI-DI
    10603295019176
    PMA / PMN Number
    P960054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. THE ADVERSE SYMPTOMS ALLEGED AND PRODUCT CODE REPORTED IS ASSOCIATED WITH THE DEPUY METAL ON METAL ARTICULATION. A COMPLAINT DATABASE SEARCH AND/OR DEVICE MANUFACTURING (DHR) REVIEWS WILL NOT BE PERFORMED. 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: A MANUFACTURING RECORD EVALUATION (MRE) WILL NOT BE PERFORMED SINCE MOM SYSTEMS ARE OBSOLETE. ADDED: D6A. CORRECTED: D6B, H6 HEALTH EFFECT - IMPACT CODE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY ORTHOPAEDICS IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY ORTHOPAEDICS HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY ORTHOPAEDICS OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY ORTHOPAEDICS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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

    SUBJECT ID: (B)(4). STUDY NO: DOTS CLINICAL ADVERSE EVENTS RECEIVED FOR DISLOCATION - REOCCURRENCE DEVICE AND PROCEDURE(RELATEDNESS) DEVICE RELATED: POSSIBLY PROCEDURE RELATED: PROBABLY DATE OF EVENT: 15/NOV/2024 DATE OF IMPLANT: NO INFORMATION PROVIDED DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: LEFT TREATMENT/IMPACT: NO INFORMATION PROVIDED DEPUY SYNTHES PRODUCT USED: CATALOG ID: 124603000 LOT ID: U55HM1000 COMPONENT TYPE: ACC DESCRIPTION: APEX HOLE ELIM POSITIVE STOP. CATALOG ID: 124754000 LOT ID: UC8A41024 COMPONENT TYPE: SHELL DESCRIPTION: DURALOC SHELL 100 SERIES 54MM CATALOG ID: 521423 LOT ID: 642458 COMPONENT TYPE: SLEEVE DESCRIPTION: SROM SLEEVE PROX ZTT 22B SM CATALOG ID: 523422 LOT ID: 822029 COMPONENT TYPE: STEM DESCRIPTION: SROM STEM STD 36MM +8L NECK 22MM X 17MM X165MM. CATALOG ID: 124954000 LOT ID: M6081K COMPONENT TYPE: RING DESCRIPTION: DURALOC DYNAMIC LOCK RING 54MM CATALOG ID: 875956 LOT ID: 3770845 COMPONENT TYPE: HEAD DESCRIPTION: SROM HEAD 32MM + 9MM CATALOG ID: 124954000 LOT ID: M5355C COMPONENT TYPE: RING DESCRIPTION: DURALOC DYNAMIC LOCK RING 54MM CATALOG ID: 124214527 LOT ID: M2068Y COMPONENT TYPE: LINER DESCRIPTION: DURALOC LINER CONSTRAINED 54MM X 32MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2523741 DURALOC CONST LINER 54X32 DURALOC IMPLANT : HIP POLY ACETABULAR LINERS KWZ DEPUY ORTHOPAEDICS INC US M2068Y 10603295019176

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention