BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOMLINK

    MDR report key: 21640508 · Received March 19, 2025

    Report

    Report Number
    3004371426-2025-00011
    Event Type
    Injury
    Date Received
    March 19, 2025
    Date of Event
    February 5, 2025
    Report Date
    February 18, 2025
    Manufacturer
    WALDEMAR LINK GMBH & CO. KG
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE ARTICLE NUMBER (B)(4) CORRESPONDS TO THE ARTICLE NUMBER (B)(4). THE REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO DEVIATIONS. THE PRODUCT COMPLIES WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURE.

    Additional Manufacturer Narrative · 0

    THE ARTICLE NUMBER 313-07694 CORRESPONDS TO THE ARTICLE NUMBER 11C007262313-07694. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO DEVIATIONS. THE PRODUCT COMPLIES WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURE. THIS IS THE FINAL SUPPLEMENTAL REPORT, THE COMPLAINT IS CLOSED.

    Description of Event or Problem · 0

    PATIENT UNDERWENT THR WITH CUSTOM TRI-FLANGE DEVICE ON (B)(6)2024 WITH NEUTRAL UNCONSTRAINED LINER (183-364/36). THE PATIENT THEN EXPERIENCED A POST-OP DISLOCATION WHICH WAS RE-OPERATED ON (B)(6)2024 DURING WHICH THE SURGEON REPLACED THE LINER WITH A CONSTRAINED LINER COMPONENT. THE PATIENT HAS SINCE DISLOCATED AGAIN AND THE SURGEON PLANS TO REVISE WITH A CONSTRAINED LINER. [CUSTOMER].

    Description of Event or Problem · 0

    PATIENT UNDERWENT THR WITH CUSTOM TRI-FLANGE DEVICE ON (B)(6) 2024 WITH NEUTRAL UNCONSTRAINED LINER (183-364/36). THE PATIENT THEN EXPERIENCED A POST-OP DISLOCATION WHICH WAS RE-OPERATED ON (B)(6) 2024 DURING WHICH THE SURGEON REPLACED THE LINER WITH A CONSTRAINED LINER COMPONENT. THE PATIENT HAS SINCE DISLOCATED AGAIN AND THE SURGEON PLANS TO REVISE WITH A CONSTRAINED LINER. [CUSTOMER]

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14145 CUSTOMLINK PPR, LEFT, TRABECULINK, 2 UNCEM.MOBILELINK CONSTR.INSERTS E HRS WALDEMAR LINK GMBH & CO. KG 313-07694

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Unknown Required Intervention