BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHREX DX REINFORCEMENT MATRIX

    MDR report key: 12061317 · Received June 24, 2021

    Report

    Report Number
    2530154-2021-00003
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Report Date
    June 24, 2021
    Manufacturer
    DSM BIOMEDICAL
    Product Code
    FTM
    PMA / PMN Number
    K091499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A POST-MARKET SURVEILLANCE SEARCH OF CLINICAL LITERATURE, THE MANUFACTURER FOUND A PAPER (POLACEK M. ARTHROSCOPIC SUPERIOR CAPSULAR RECONSTRUCTION WITH ACELLULAR PORCINE DERMAL XENOGRAFT FOR THE TREATMENT OF MASSIVE IRREPARABLE ROTATOR CUFF TEARS. ARTHROSC SPORTS MED REHABIL. 2019 NOV 13;1(1):E75-E84.) WHICH OUTLINES THAT PATIENT #6 EXPERIENCED A COMPLICATION POSTOPERATIVE AFTER THE IMPLANTATION OF ARTHREX DX REINFORCEMENT MATRIX AS PART OF SUPERIOR CAPSULAR RECONSTRUCTION (SCR) SURGERY. THE PATIENT EXPERIENCED AN ADVERSE REACTION DESCRIBED AS AN "ACUTE IMMUNOLOGIC REACTION" (PAIN, SWELLING, SECRETION) BUT THERE WAS NO SURGICAL SITE INFECTION. REVISIONAL SURGERY WAS PERFORMED AND THE SURGEON NOTED THAT THE DEVICE HAD DEGRADED INTO WHITE PARTICLES. THE DEVICE WAS EXPLANTED. PATIENT EXPERIENCED CLINICAL IMPROVEMENT DURING REHABILITATION AND DID NOT REQUIRE FURTHER SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    DURING A POST-MARKET SURVEILLANCE SEARCH OF CLINICAL LITERATURE, THE MANUFACTURER FOUND A PAPER (POLACEK M. ARTHROSCOPIC SUPERIOR CAPSULAR RECONSTRUCTION WITH ACELLULAR PORCINE DERMAL XENOGRAFT FOR THE TREATMENT OF MASSIVE IRREPARABLE ROTATOR CUFF TEARS. ARTHROSC SPORTS MED REHABIL. 2019 NOV 13;1(1):E75-E84.) WHICH OUTLINES THAT PATIENT #6 EXPERIENCED A COMPLICATION POSTOPERATIVE AFTER THE IMPLANTATION OF ARTHREX DX REINFORCEMENT MATRIX AS PART OF SUPERIOR CAPSULAR RECONSTRUCTION (SCR) SURGERY. THE PATIENT EXPERIENCED AN ADVERSE REACTION DESCRIBED AS AN "ACUTE IMMUNOLOGIC REACTION" (PAIN, SWELLING, SECRETION) BUT THERE WAS NO SURGICAL SITE INFECTION. REVISIONAL SURGERY WAS PERFORMED AND THE SURGEON NOTED THAT THE DEVICE HAD DEGRADED INTO WHITE PARTICLES. THE DEVICE WAS EXPLANTED. PATIENT EXPERIENCED CLINICAL IMPROVEMENT DURING REHABILITATION AND DID NOT REQUIRE FURTHER SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957365 ARTHREX DX REINFORCEMENT MATRIX MESH, SURGICAL, PRODUCT CODE: FTM FTM DSM BIOMEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention