BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOLOX DELTA HEAD 12/14 32X0

    MDR report key: 8324804 · Received February 11, 2019

    Report

    Report Number
    0009613350-2019-00050
    Event Type
    Malfunction
    Date Received
    February 11, 2019
    Date of Event
    January 16, 2019
    Report Date
    July 30, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    K071535
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. DHR REVIEW: REF#: 00-8775-032-02, LOT#: 2953818. YIELD: (B)(4). DELIVERED: (B)(4). THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TRIGGER CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: COSMETIC : SCRATCH DAMAGE. EVENT DESCRIPTION: IT WAS REPORTED THAT UPON OPENING OF CERAMIC HEAD, IT HAD WHAT APPEARED TO BE A SMALL SCRATCH ON THE SURFACE, WHICH WAS THEN NOTICED WHEN THE HEAD WAS INSERTED ONTO THE STEM. ANOTHER HEAD WAS OPENED AND IMPLANTED ON THE STEM. REVIEW OF RECEIVED DATA: PICTURE OF THE HEAD IS RECEIVED. IT SHOWS THAT THERE IS A SLIGHT METAL TRANSFER LINE VISIBLE ON THE ARTICULATING SURFACE OF THE HEAD. DEVICES ANALYSIS: VISUAL EXAMINATION: THE CERAMIC HEAD WAS RECEIVED FOR THE INVESTIGATION. SLIGHT METAL TRANSFER IN FORM OF A SHORT LINE AND ALSO POINTS ARE VISIBLE ON THE ARTICULATING SURFACE OF THE HEAD. THERE IS FURTHER METAL TRANSFER OBSERVED ON THE TAPER AREA OF THE CERAMIC HEAD WHICH IS DUE TO THE CONTACT WITH THE STEM TAPER UPON SEATING THE HEAD ON THE STEM. REVIEW OF PRODUCT DOCUMENTATION: THIS DEVICE IS INTENDED FOR TREATMENT. COMPATIBILITY: COMPATIBILITY CHECK COULD NOT BE PERFORMED AS ONLY ONE PRODUCT HAD BEEN REPORTED. ACCORDING INSPECTION PLAN: SURFACE POLISH IS 100% VISUALLY INSPECTED. CONCLUSION SUMMARY: THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). VISUAL EXAMINATION OF THE HEAD CONFIRMED THE SCRATCHES PRESENT ON THE HEAD. HOWEVER, IT CANNOT BE KNOWN WITH CERTAINTY WHEN THE SCRATCHES HAPPENED. IT IS POSSIBLE THAT WRONG HANDLING DURING THE IMPLANTATION OR A POTENTIAL PACKAGING DAMAGE MIGHT HAVE LED TO THE SCRATCHES OBSERVED. 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).

    Description of Event or Problem · 0

    INVESTIGATION RESULTS ARE NOW AVAILABLE.

    Additional Manufacturer Narrative · 1

    PICTURES WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. THE MANUFACTURER DID NOT RECEIVE THE DEVICE YET, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY A SCRATCH ON A CERAMIC HEAD WAS NOTICED. THE CERAMIC HEAD WAS NOT IMPLANTED, ANOTHER IMPLANT WAS USED THEN. NOTES: THE IMPLANTATION AND EXPLANTATION DATES ARE LEFT EMPTY AS THE DEVICE WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122021 BIOLOX DELTA HEAD 12/14 32X0 BIOLOX DELTA CERAMIC FEMORAL HEAD LZO ZIMMER GMBH N/A 2953818

    Patients

    Seq Age Sex Outcome Treatment
    1