BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURASUL, ALPHA INSERT, HH/32

    MDR report key: 7564321 · Received June 4, 2018

    Report

    Report Number
    0009613350-2018-00571
    Event Type
    Malfunction
    Date Received
    June 4, 2018
    Date of Event
    May 9, 2018
    Report Date
    October 17, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: FOREIGN MATERIAL IN PACKAGING. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT DURING A HIP SURGERY A FOREIGN MATERIAL WAS FOUND IN THE INNER BLISTER OF A DURASUL ALPHA INSERT¿S PACKAGING. THE FOREIGN MATERIAL SHOWS RED DEPOSITS ADHERING TO IT. REVIEW OF RECEIVED DATA: RECEIVED PHOTOS CONFIRM SOME FOREIGN MATERIAL IN THE BLISTER. THE RESIDUES AT HAND SHOWS A KIND OF A WHITE SPIRAL SHAPED BURR (SPAN) WITH RED COLORED RESIDUES ON IT. DEVICES ANALYSIS: VISUAL EXAMINATION AND MATERIAL ANALYSIS: THE PACKAGING WITH THE FOREIGN MATERIAL WAS SENT BACK FOR INVESTIGATION TO ZIMMER BIOMET, WINTERTHUR. IN THE AS-RECEIVED CONDITION IT WAS FIXED WITH AN ADHESIVE TAPE TO THE UPPER SIDE OF THE RETAINER. THE FOREIGN MATERIAL HAS RED DEPOSITS ADHERING TO IT. THE VISUAL INSPECTION REVEALED THAT THE FORM AND RECOILING BEHAVIOR OF THE FOREIGN MATERIAL IS SIMILAR TO THAT OF POLYETHYLENE CHIPS RESULTING FROM THE MACHINING PROCESS OF THE PRODUCT (E.G. TURNING). FURTHER, THE FOREIGN MATERIAL WAS DETERMINED TO BE POLYETHYLENE. THE MATERIAL DETERMINATION WAS PERFORMED VIA FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS WITH A DEVICE TYPE AGILENT VARIAN 670 IR. THE ATR-FTIR SPECTRA OF THE SAMPLE AND THE REFERENCE (A PIECE OF A COARSE SULENE-PE RIBBON WAS CHOSEN AS REFERENCE) WERE IN GENERAL THE SAME AND THE PEAKS ARE CHARACTERISTIC FOR POLYETHYLENE. BASED ON THIS, IT IS SUSPECTED THAT THE FOREIGN MATERIAL IS PROBABLY A CHIP DERIVING FROM THE MACHINING OF THE DURASUL, ALPHA INSERT THAT WAS STILL CONNECTED TO THE INSERT DURING THE PACKAGING PROCESS, CAME OFF LATER ON AND REMAINED IN THE INNER BLISTER. THE EVALUATION OF RED DEPOSITS WAS PERFORMED WITH A COBAS, COMBUR TEST UX STRIPE (ROCHE DIAGNOSTICS GMBH, MANNHEIM, D). COMPARED TO THE COLOR SCALE OF THE PRODUCT LABEL, THE TEST STRIPE SHOWED THAT ACCORDING TO THE INSTRUCTIONS FOR USE THE COLOR CHANGE (HB_HEMOGLOBIN) CAN BE ASCRIBED TO BLOOD. THE FOREIGN MATERIAL WAS CONTAMINATED WITH BLOOD. THIS COULD EITHER DERIVE FROM MANUFACTURING, MOST PROBABLY DURING THE PACKAGING PROCESS, OR THE SURGERY. AS THE PACKAGING PROCESS IS PERFORMED WITH GLOVES IT IS UNLIKELY THAT THE CONTAMINATION OCCURRED DURING PACKAGING. IF THE CONTAMINATION OCCURRED IN THE OPERATION ROOM IT IS UNKNOWN HOW AND AT WHICH POINT IN TIME IT CAME TO IT AS THE FOREIGN MATERIAL WAS FOUND IN THE INNER BLISTER OF THE PACKAGING. IT CAN BE STATED THAT THE FOREIGN MATERIAL IS POLYETHYLENE AND THAT THE RED DEPOSITS ADHERING TO IT ARE BLOOD. REVIEWING THE MANUFACTURING DOCUMENTS OF LOT 2936293 FOLLOWING INSPECTIONS WERE CONDUCTED: DURING TURNING (DREHEN) AND ENGRAVING (GRAVIEREN) 100% VISUELL SURFACE INSPECTION DURING FINAL INSPECTION (SCHLUSSPRÜFUNG) 100% VISUELL SURFACE INSPECTION IT WAS REPORTED THAT DURING A HIP SURGERY A FOREIGN MATERIAL WAS FOUND IN THE INNER BLISTER OF A DURASUL ALPHA INSERT¿S PACKAGING. THE FOREIGN MATERIAL SHOWS RED DEPOSITS ADHERING TO IT. IT CAN BE STATED THAT THE FOREIGN MATERIAL IS POLYETHYLENE AND THAT THE RED DEPOSITS ADHERING TO IT ARE BLOOD. DURING THE INTERNAL MANUFACTURING PROCESS TWO 100% VISUAL INSPECTIONS WERE CONDUCTED. ONE DURING THE TURNING/ENGRAVING STEP AND ONE DURING FINAL INSPECTION. IT IS VERY UNLIKELY THAT SUCH A BIG RESIDUE WAS NOT DETECTED. BASED ON THE GIVEN INFORMATION AND WITH THE OUTCOME OF THE INVESTIGATION THE ROOT CAUSE FOR THIS ISSUE CANNOT BE DETERMINED. THE REPORTED EVENT CAN BE CONSIDERED AS SINGLE CASE, SINCE NO FURTHER COMPLAINT WITH A SIMILAR EVENT (POLYETHYLENE RESIDUES) COULD BE FOUND FOR PACKAGING CONFIGURATION 38GP. FURTHERMORE, CHECKING THE WAREHOUSES IN THE COUNTRIES SHOWS THAT NO MORE PARTS OF THE LOT 2936293 ARE AVAILABLE AND NO FURTHER, SIMILAR COMPLAINTS ARE REPORTED FORT THIS LOT NUMBER. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE REPORTED IS NOT MARKETED IN USA, BUT DEVICES WITH SIMILAR CHARACTERISTICS (I.E REF 01.00013.409, K013935) ARE MARKETED IN USA, AND THEREFORE THIS REPORT WAS FILED. THE MANUFACTURER RECEIVED THE DEVICE (PACKAGING) AND INVESTIGATION IS IN PROGRESS. PICTURES WERE RECEIVED AND WILL BE REVIEWED WITHIN THE INVESTIGATION. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICE, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. AN E-MAIL REQUESTING THE FOLLOWING ADDITIONAL INFORMATION WAS SENT ON MAY 15, 2018 TO THE RESPONSIBLE PERSON WHO INITIATED THIS COMPLAINT: PATIENT IDENTIFIERS. IS THERE ANY FOLLOW UP SCHEDULED TO MONITOR THE PATIENT FOR INFECTION SYMPTOMS? A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4)..

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DIRT RESIDUES WERE FOUND DURING SURGERY IN THE INNER BLISTER OF THE PACKAGING, WITH THE INLAY. THE PRODUCT HAS BEEN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408345 DURASUL, ALPHA INSERT, HH/32 DURASUL, ALPHA INSERT LZO ZIMMER GMBH N/A 2936293

    Patients

    Seq Age Sex Outcome Treatment
    1 Other