BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOLOX DELTA CER HEAD 28 12/14

    MDR report key: 4948961 · Received July 27, 2015

    Report

    Report Number
    9613350-2015-00836
    Event Type
    Other
    Date Received
    July 27, 2015
    Date of Event
    July 1, 2015
    Report Date
    July 1, 2015
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RECEIVED FOR INVESTIGATION AND THE RESULTS WERE MADE AVAILABLE. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO TREND WAS IDENTIFIED. THE COMPATIBILITY CHECK COULD NOT BE PERFORMED AS ONLY ONE PRODUCT WAS REPORTED TO US. THE PRODUCT COMPATIBILITY CHECK IS NOT RELEVANT FOR ONE PRODUCT ONLY. IT WAS REPORTED THAT THE SURGEON FOUND SCRATCHES ON THE ARTICULATING SURFACE OF A BIOLOX HEAD AFTER UNPACKING. A USE ERROR COULD NOT BE EXCLUDED. NO OTHER SOURCE DOCUMENT WAS PROVIDED. VISUAL EXAMINATION: THE ARTICULATING SURFACE OF THE BIOLOX HEAD SHOWS LITTLE BLACK SPOTS. THE TAPER SHOWS CIRCUMFERENTIAL METAL TRANSFER DERIVING FROM A STEM TAPER. REVIEW OF INTERNAL DOCUMENTS: INSPECTION PLAN SAP, CHARACTERISTICS #4: SURFACE POLISH IS 100% VISUALLY INSPECTED. THE REVIEW OF THE DHR INDICATES THAT THE HEAD MET ALL REQUIREMENTS TO PERFORM AS INTENDED. MOREOVER, THE SURFACE OF THE HEAD IS 100% VISUALLY INSPECTED BEFORE IT IS RELEASED. THE CIRCUMFERENTIAL METALLIC TRANSFER IN THE TAPER INDICATES THAT THE BIOLOX HEAD HAS BEEN ALREADY ASSEMBLED ONTO THE STEM TAPER. THEREFORE, IT CAN BE ASSUMED THAT THE MARKS ON THE ARTICULATION SURFACE EMERGED FROM A HANDLING ERROR AFTER IT WAS TAKEN OUT OF THE PACKAGING. HANDLING OF THE COMPONENT IS OUTSIDE OF ZIMMER BIOMET CONTROL. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE COULD IDENTIFY A ROOT CAUSE FOR THIS ISSUE. WE CONSIDER USE ERROR AS ROOT CAUSE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SURGERY WAS PLANNED WITH A BIOLOX DELTA CER HEAD 28 12/14, BUT A SCRATCH ON THE SPHERE SURFACE WAS DISCOVERED. IT WAS REPORTED THAT THE SURGERY WAS COMPLETED W/AN ALTERNATIVE HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486129 BIOLOX DELTA CER HEAD 28 12/14 BIOLOX DELTA CERAMIC FEMORAL HEAD LZO ZIMMER GMBH 2784871

    Patients

    Seq Age Sex Outcome Treatment
    1 Other