BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSTHESIS - UNIVERSAL TITANIUM PROSTHESIS

    MDR report key: 5447998 · Received February 19, 2016

    Report

    Report Number
    1045254-2016-00047
    Event Type
    Malfunction
    Date Received
    February 19, 2016
    Date of Event
    January 27, 2016
    Report Date
    January 27, 2016
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETA
    PMA / PMN Number
    K002897
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 1150000 ¿ PROSTHESIS, UNIVERSAL TITANIUM RO; LOT ¿ 0205455836; MANUFACTURE DATE ¿ OCTOBER 4, 2011; USE BEFORE DATE ¿ OCTOBER 2, 2019; 510K - K002897 1150050 ¿ PROSTHESIS, UNIVERSAL TITANIUM VI; LOT ¿ 0205577879; MANUFACTURE DATE ¿ NOVEMBER 29, 2011; USE BEFORE DATE ¿ NOVEMBER 27, 2019; 510K ¿ K002897 1150050 ¿ PROSTHESIS, UNIVERSAL TITANIUM VI; LOT ¿ 0206234969; MANUFACTURE DATE ¿ OCTOBER 9, 2012; USE BEFORE DATE ¿ OCTOBER 7, 2020; 510K - K002897. (B)(4). 1150000, LOT NUMBER 0205455047: ONE UN-SEALED SAMPLE WAS RECEIVED. THERE WAS EVIDENCE OF BIOLOGICAL CONTAMINANTS BASED OFF OF THE REACTIVITY WITH HYDROGEN PEROXIDE. WHEN COMPARED TO THE ASSEMBLY DRAWING, THERE WAS NO DAMAGE TO THE PACKAGING TO INDICATE A CAUSE FOR THE COMPLAINT AND THE DEVICE IS SHIPPED IN A RIGID CAPSULE. THE FLEX H/A WAS NOT RETURNED. THE TITANIUM BELL LEGS AND HEAD/SHAFT ASSEMBLY SHOWED SIGNS OF DEFORMATION. THERE WERE NO SIGNS THAT THE DEVICE WAS CLOSED IN THE LID OF THE CAPSULE. THE BELL SHOWED SIGNS OF A RESIDUE CONSISTENT WITH ADHESIVE IN THE AREA THAT ATTACHES THE FLEX H/A WHICH LIKELY INDICATES THE DEVICE WAS MANUFACTURED PER THE DRAWING. THE CONTAMINANTS COMBINED WITH THE OBSERVED DAMAGE LIKELY INDICATE THE ISSUE OCCURRED WHILE HANDLING. 1150000, LOT NUMBER 0205455836: ONE UN-SEALED SAMPLE WAS RECEIVED. THERE WAS EVIDENCE OF BIOLOGICAL CONTAMINANTS BASED OFF OF THE R EACTIVITY WITH HYDROGEN PEROXIDE. WHEN COMPARED TO THE ASSEMBLY DRAWING, ONLY THE FLEX H/A WAS RETURNED WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT. WHEN VIEWED UNDER MAGNIFICATION, THERE WAS EVIDENCE THE FLEX H/A WAS ATTACHED AT SOME POINT TO THE BELL BASED OFF OF THE MOUNTING AREA. THERE WAS NO DAMAGE TO THE PACKAGING TO INDICATE A CAUSE FOR THE COMPLAINT AND THE DEVICE IS SHIPPED IN A RIGID CAPSULE. THE CONTAMINANTS COMBINED WITH THE OBSERVED DAMAGE LIKELY INDICATE THE ISSUE OCCURRED WHILE HANDLING. 1150050, LOT NUMBER 0205577879: ONE UN-SEALED SAMPLE WAS RECEIVED. THERE WAS EVIDENCE OF BIOLOGICAL CONTAMINANTS BASED OFF OF THE R EACTIVITY WITH HYDROGEN PEROXIDE. WHEN COMPARED TO THE ASSEMBLY DRAWING AND VIEWED UNDER MAGNIFICATION, THERE WAS A RESIDUE CONSISTENT WITH ADHESIVE PRESENT WHERE THE FLEX H/A MOUNTS TO THE BELL, WHICH IS CONSISTENT WITH PROPER MANUFACTURING. THE FLEX H/A WAS SEPA RATED FROM THE TITANIUM BELL AT THE ADHESIVE JOINT AND WAS NOT RETURNED. THE HEAD/SHAFT ASSEMBLY MEASURED LESS THAN 0.23¿ [REQUIRED IS 0.400+-.012] AND THE SHAFT WAS CONSISTENT WITH BEING TRIMMED. THE CONTAMINANTS COMBINED WITH THE OBSERVED DAMAGE LIKELY INDICATE THE ISSUE OCCURRED WHILE HANDLING. 1150050, LOT NUMBER 0206234969: ONE UN-SEALED SAMPLE WAS RECEIVED. THERE WAS EVIDENCE OF BIOLOGICAL CONTAMINANTS BASED OFF OF THE R EACTIVITY WITH HYDROGEN PEROXIDE. WHEN COMPARED TO THE ASSEMBLY DRAWING AND VIEWED UNDER MAGNIFICATION, THERE WAS A RESIDUE CONSISTENT WITH ADHESIVE PRESENT WHERE THE FLEX H/A MOUNTS TO THE BELL, WHICH IS CONSISTENT WITH PROPER MANUFACTURING. THE BELL LEGS WERE DE FORMED. THE FLEX H/A WAS SEPARATED FROM THE TITANIUM BELL AT THE ADHESIVE JOINT. THE HEAD/SHAFT ASSEMBLY MEASURED LESS THAN 0.19¿ [REQUIRED IS 0.400+-.012] AND THE SHAFT WAS CONSISTENT WITH BEING TRIMMED. THE CONTAMINANTS COMBINED WITH THE OBSERVED DAMAGE LIKELY I NDICATE THE ISSUE OCCURRED WHILE HANDLING. H10. BLANK FIELDS ON THIS REPORT ARE THE RESULT OF INFORMATION NOT BEING PROVIDED BY INITIAL REPORTER. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Description of Event or Problem · 1

    INTRAOPERATIVE, THE SHOE OF FOUR PROSTHESIS DEVICES DROPPED (DETACHED). THERE WAS NO INJURY REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105860 PROSTHESIS - UNIVERSAL TITANIUM PROSTHESIS REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL ETA MEDTRONIC XOMED INC. 1150000 0205455047

    Patients

    Seq Age Sex Outcome Treatment
    1