BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ANKLE TALAR

    MDR report key: 9468353 · Received December 13, 2019

    Report

    Report Number
    1818910-2019-118940
    Event Type
    Injury
    Date Received
    December 13, 2019
    Date of Event
    January 1, 2014
    Report Date
    November 19, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HSN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW, WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT NUMBER WAS NOT PROVIDED. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). (B)(4) USED TO CAPTURE MEDICAL DEVICE REMOVAL AND SURGICAL INTERVENTION. 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 · 1

    THE LITERATURE ARTICLE ENTITLED ¿MANAGEMENT OF EXTENSIVE TALAR OSTEOLYSIS WITH AGILITY TOTAL ANKLE REPLACEMENT SYSTEMS USING GEOMETRIC METAL-REINFORCED POLYMETHYLMETHACRYLATE CEMENT AUGMENTATION¿, BY THOMAS S. ROUKIS, DPM, PHD, FACFS, ET AL, PUBLISHED IN THE JOURNAL OF FOOT AND ANKLE SURGERY, 53 (2014), 108-113; WAS REVIEWED. THE PURPOSE OF THE ARTICLE WAS TO DESCRIBE A TECHNIQUE FOR THE MANAGEMENT OF MASSIVE CYSTIC CHANGES AND BONE LOSS SECONDARY TO ASEPTIC OSTEOLYSIS AND SUBSIDENCE OF THE TALAR COMPONENT OF FAILED AGILITY TOTAL ANKLE REPLACEMENT SYSTEMS. THE ARTICLE DESCRIBES THIS AS AN MANAGEMENT OF EXTENSIVE TALAR OSTEOLYSIS ASSOCIATED WITH FAILED AGILITY TOTAL ANKLE REPLACEMENT SYSTEMS, THEY USED GEOMETRIC METAL-REINFORCED POLYMETHYLMETHACRYLATE CEMENT AUGMENTATION. THIS TECHNIQUE PRESERVES THE SUBTALAR JOINT AND PROVIDES IMMEDIATE COMPONENT STABILITY AND RESTORATION OF COMPONENT ALIGNMENT AND HEIGHT. IT IS ALSO A COST-EFFECTIVE ALTERNATIVE TO THE OTHER AVAILABLE OPTIONS AND STILL ALLOWS FOR ADDITIONAL REVISION SHOULD LATE FAILURE OCCUR. THE OPTIONS FOR REVISION OF THE TALAR COMPONENT DEPEND ON WHETHER THE FAILED SYSTEM WAS AN AGILITY OR AGILITY LP TARS. THE REVISIONS INCLUDED A TALAR COMPONENT AND AN INSERT; SIZES WERE DETERMINED BASED UPON WHICH IMPLANT WAS BEING REVISED. THE AUTHORS ALSO REPORT THAT THIS TECHNIQUE HAS NOT BEEN THOROUGHLY STUDIED TO DATE FOR REVISION TOTAL ANKLE REPLACEMENT. ALTHOUGH, IT HAS WORKED WELL IN THE THREE PATIENTS THEY HAVE TREATED, ADDITIONAL STUDY IS WARRANTED BEFORE WIDESPREAD USE CAN BE ADVOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264497 UNKNOWN ANKLE TALAR ANKLE TALAR HSN DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention