BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLOFIT ALLOCLASSIC SHELL 58/LL

    MDR report key: 4798270 · Received May 26, 2015

    Report

    Report Number
    9613350-2015-00616
    Event Type
    Malfunction
    Date Received
    May 26, 2015
    Date of Event
    May 7, 2015
    Report Date
    May 7, 2015
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, PHOTOS OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. SHOULD ADD'L INFO BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGE THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    POSSIBLE CAUSES FOR THE REPORTED EVENT ACCORDING TO DFMEA. BAG WAS NOT TIGHT , PRODUCT NOT COMPLETELY PROTECTED FROM ENVIRONMENT , PART NOT FIXED IN VACUUMIZED BAG, BURST OF BAG WELDING, NOT TIGHT STERILE BARRIER, DUE TO CONFUSION WITH ROUTER PAPER, ERROR DURING HANDWRITING WHEN SCANNER WAS BROKEN. NOT POSSIBLE AS ROUTER PAPER FOR LOT 2780701 DID NOT STATE ANY ERROR RELATED TO THAT. NOT VISIBLE VACUUMIZED PRODUCT, NOT FIXED IN THE VACUUMIZED BAG, DELAY OF SURGERY, DUE TO DAMAGED VACUUM MACHINE. NOT POSSIBLE AS THE VACUUM WELDING WAS COMPLETELY INTACT. BAG WAS NOT TIGHT (IVP/AVP), STERILE BARRIER AFFECTED, DUE TO HAIR IN THE CONTACT AREA BETWEEN TWO POLYMER LAYERS: NOT POSSIBLE AS NO PART WAS FOUND TO BE IN CONTACT WITH THE LAYER. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. OUR INVESTIGATION AND OUR PRODUCTION RECORDS DID NOT INDICATE ANY INCIDENTS DURING MANUFACTURING PROCESS. THE REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THE DEVICE WAS MANUFACTURED, WASHED AND PACKAGED ACCORDING TO DEFINED SPECS WITH NO REPORTED NON-CONFORMITIES REGARDING THE STERILE BARRIER. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AT THIS POINT OF TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING OPERATION PROF. (B)(6) RECOGNIZED A HOLE IN THE STERIL PLASTIC BAG AND DID NOT USE THE ALLOFIT CUP BECAUSE OF RISK OF CONTAMINATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON JULY 28, 2015. IT WAS REPORTED THAT DURING SURGERY A HOLE IN THE STERILE PLASTIC BAG WAS DETECTED. THE AFFECTED DEVICE WAS RETURNED FOR INVESTIGATION. THE VISUAL EXAMINATION CONFIRMED THE REPORTED ERROR PATTERN. A HOLE IN THE STERILE PACKAGING COULD BE SEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341267 ALLOFIT ALLOCLASSIC SHELL 58/LL ALLOFIT ALLOCLASSIC SHELL 58/LL KWB ZIMMER GMBH 2780701

    Patients

    Seq Age Sex Outcome Treatment
    1