BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMMERLOCK MEDIUM ANGLED

    MDR report key: 2732607 · Received August 31, 2012

    Report

    Report Number
    MW5026792
    Event Type
    Injury
    Date Received
    August 31, 2012
    Date of Event
    March 20, 2012
    Report Date
    August 31, 2012
    Manufacturer
    BME BIOMEDICAL ENTERPRISES, INC.
    Product Code
    HTY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADMITTED AS AN OUT PT TO (B)(6), FOR FUSION LEFT FOOT SECOND DIGIT PROXIMAL INTERPHALANGEAL JOINT (2825) WITH BUNIONECTOMY. HAMMERLOCK IMPLANT: MEDIUM ANGLED LOT # BMEHL111182 WAS INSERTED INTO THE SECOND DIGIT. AFTER 4 MONTHS OF LEFT FOOT EDEMA, PAIN, MEDICATIONS, IMMOBILIZATION, COMPRESSION THERAPY, AND PHYSICAL THERAPY, THE DOCTOR AND XRAYS CONFIRMED MY CONCERNS REGARDING BOTH THE HAMMERLOCK IMPLANT'S INABILITY TO FUSE (NONUNION) AND ITS PARTICULAR ALLOY (NITINOL). THE HAMMERLOCK IMPLANT IS UNIQUE IN THAT IT IS MFG AS A INTRAMEDULLARY NITINOL FIXATION SYSTEM. THE MFG COMPANY IS BIOMEDICAL ENTERPRISES, INC ITS WEBSITE IS (B)(4). I ALSO FOUND FURTHER INFO AT (B)(4). I AGREED FOR ITS REMOVAL ON (B)(6) 2012, BASED ON THE DOCTOR'S DIAGNOSIS OF A NONUNION, METAL REACTION, AND POSSIBLY A METAL ALLERGY. IN OTHER WORDS, IT DID NOT LIVE UP TO ITS WORD TO FUSE AND HEAL ACCORDINGLY AS WELL AS DECREASING COMPLICATIONS AND PROVIDING MORE CONVENIENCE PER ITS WEBSITE. ALSO, THE USAGE OF ITS ALLOY, NITINOL, IS TO BE STRONGLY FACTORED AT THIS TIME. THEREFORE, I CONSIDER THE IMPLANT TO BE BOTH AN "ADVERSE EVENT" (METAL REACTION - NITINOL) AS AN IMPORTANT MEDICAL EVENT AND A "PRODUCT PROBLEM" (DEFECTIVE/MALFUNCTION). IMMEDIATELY UPON SURGICAL REMOVAL, PHYSICAL RELIEF WAS DRAMATICALLY NOTED. IF FURTHER INFO IS NEEDED, PLEASE CONTACT ME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAMMERLOCK MEDIUM ANGLED HAMMERLOCK HAMMER TOE LOCK HTY BME BIOMEDICAL ENTERPRISES, INC. BMEHL111182

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other| R SMART TOE