BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOLOX DELTA, CERAMIC FEMORAL HEAD, L 32/3.5, TAPER 12/14

    MDR report key: 8024119 · Received October 31, 2018

    Report

    Report Number
    0009613350-2018-01102
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    October 5, 2018
    Report Date
    April 7, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. DHR-REVIEW: REF#: (B)(4), LOT#: 2945945, YIELD: 100, DELIVERED: 100. 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: CONTAMINATION OF THE IMPLANT DURING OR. EVENT DESCRIPTION: IT WAS REPORTED THAT AFTER OPENING STERILE PACKAGING, A FOREIGN SUBSTANCE ATTACHED TO THE SLIDING SURFACE OF THIS HEAD. THIS SURGERY WAS FINISHED WITH ALTERNATIVE PRODUCT. REVIEW OF RECEIVED DATA: PHOTO OF THE BIOLOX HEAD WITH A FOREIGN PARTICLE ATTACHED ON ITS ARTICULAR SURFACE IS RECEIVED. DEVICES ANALYSIS: FOR THE INVESTIGATION OF THE COMPLAINT ONE FEMORAL HEAD AND A FOREIGN PARTICLE, WHICH IS AS THIN AS PAPER AND HAS AROUND 6MM2 AREA, WERE RECEIVED SEPARATELY. VISUAL EXAMINATION OF THE BIOLOX DELTA HEAD SHOWED NO DEFICIENCIES EXCEPT THE METAL TRANSFER LINES WHICH WERE FOUND ON THE TAPER AREA (DUE TO METALLIC STEM TAPER CONTACT). NO ABNORMALITIES WAS OBSERVED ON THE ARTICULAR SURFACE OF THE HEAD. THE DIRT PARTICLE SEEMS TO BE PAPER ORIGINED AND IS RECEIVED IN STERILE PACKAGE, BUT NOT AS ATTACHED ON THE FEMORAL HEAD AS IT WAS SEEN IN THE PHOTO. REVIEW OF PRODUCT DOCUMENTATION: NO PRODUCT DOCUMENTATION WAS REVIEWED FOR INVESTIGATION. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING RMW: INCREASED WEAR DUE TO INADEQUATE HANDLING OF THE MEDICAL DEVICE IN THE OR LEADING TO CONTAMINATED DEVICE (E.G. FOREIGN PARTICLES PRESENT IN COP AND COC PAIRING POSTOPERATIVELY LEADING TO INCREASED WEAR). POSSIBLE, THE DIRT HAS ATTACHED ON THE SURFACE OF THE HEAD DURING HANDLING OF THE DEVICE. CONCLUSION SUMMARY: ACCORDING THE EVENT UPON OPENING THE PACKAGE OF THE PRODUCT A FOREIGN SUBSTANCE ATTACHED TO THE SURFACE OF THIS HEAD. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. ALL PRODUCTS ARE CLEANED BEFORE BEING PACKED IN THE STERILE PACKAGES. EXAMINATION OF THE HEAD SHOWS THAT THE SURGEON ALREADY TRIED SEATING THE HEAD ON THE STEM. WHILE THERE IS A PARTICLE ON THE HEAD IT SHOULD NOT BE POSSIBLE TO SEAT THE HEAD. THEREFORE, IT IS ASSUMED THAT THERE WAS NO DIRT PARTICLE ON THE HEAD DURING SEATING. HENCE, THE ATTACHMENT OF THAT FOREIGN PARTICLE MUST HAVE HAPPENED AFTER THIS EVENT. THE ATTACHMENT OF THE FOREIGN PARTICLE ONTO THE PRODUCT IS NOT A FAILURE OF THE PRODUCT, BUT OF THE HOSPITAL. THE OP ROOM SHOULD BE CLEAN AND DURING HANDLING OF THE PRODUCT GOOD CARE SHOULD BE GIVEN SO THAT PRODUCT DOES NOT GET CONTAMINATED BY ANY MEANS. THEREFORE, BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. THE ROOT CAUSE IS INAPPROPRIATE HANDLING OF THE DEVICE. 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

    THERAPY DATE : UNKNOWN. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED 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. 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 FOREIGN MATERIAL WAS ATTACHED TO SURFACE OF THE IMPLANT AFTER OPENING STERILE PACKAGING. THE SURGERY WAS FINISHED WITH ALTERNATIVE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862752 BIOLOX DELTA, CERAMIC FEMORAL HEAD, L 32/3.5, TAPER 12/14 BIOLOX DELTA, CERAMIC FEMORAL HEAD LZO ZIMMER GMBH N/A 2945945

    Patients

    Seq Age Sex Outcome Treatment
    1 Other