BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA CER FEM HD 032/0MM 12/14 M 12/14

    MDR report key: 9720071 · Received February 18, 2020

    Report

    Report Number
    3002806535-2020-00087
    Event Type
    Malfunction
    Date Received
    February 18, 2020
    Date of Event
    January 17, 2020
    Report Date
    July 16, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, D10, G4, G7, H1, H2, H3, H4, H6, H10. G3: REPORT SOURCE, FOREIGN - EVENT OCCURRED IN GERMANY. PRODUCTS HAVE BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION ON LINKED COMPLAINT (B)(4) AND FORWARDED TO THE PRODUCT EVALUATION COMPLAINTS ENGINEER FOR INVESTIGATION, EVALUATION SUMMARY IS AS FOLLOWS: THE EVENT REPORTS THAT IT WAS IDENTIFIED THAT THAT THE TOP FOAM WAS ADHERED TO THE TYVEK LID. THIS EVENT OCCURRED DURING SURGERY. THE SAME DEVICE WAS USED TO COMPLETE THE SURGERY. NO FURTHER INFORMATION HAS BEEN PROVIDED. THE COMPLAINT HAS BEEN CONFIRMED FOLLOWING REVIEW OF THE RETURNED PACKAGING, WHICH CONFIRMED THE FOAM HAS ADHERED TO THE TYVEK LID. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A COMPLAINT HISTORY REVIEW IDENTIFIED SIX SIMILAR COMPLAINTS FOR THE SAME ITEM NUMBER. A COMPLAINT HISTORY REVIEW IDENTIFIED ONE SIMILAR COMPLAINT FOR THE SAME LOT NUMBER. THIS DEVICE IS USED FOR TREATMENT. THE REPORTED EVENT IS NOT RELATED TO A COMBINATION OF PRODUCTS; THEREFORE, A COMPATIBILITY REVIEW IS NOT APPLICABLE. THE IFU PROVIDED WITH THE DEVICE STATES TO CHECK THE PACKAGING FOR DAMAGE BEFORE USE. THE LIKELY CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET IS NON-CONFORMING TO SPECIFICATION. THE CORRECT PACKAGING MATERIALS AND SEALING METHODS HAVE BEEN USED. THE LIKELY CAUSE OF THE REPORTED EVENT IS NOT ENOUGH CLEARANCE BETWEEN THE TOP FOAM AND THE TYVEK LID DURING THE HEAT SEALING PROCESS. THIS CAUSES UNINTENDED HEAT TRANSFERS BETWEEN THE TOP FOAM AND THE TYVEK LID, RESULTING IN ADHESION. THE INDENT IN THE TOP FOAM (WHICH HAVE BEEN CAUSED BY COMPRESSION FROM THE DEVICE) FURTHER INDICATE THAT THE SPACE WITHIN THE BLISTER WOULD HAVE BEEN LIMITED. RISK ASSESSMENT: THIS EVENT OCCURRED DURING SURGERY. NO FURTHER INFORMATION HAS BEEN PROVIDED. THE SEVERITY OF THE REPORTED EVENT AND THE CALCULATED OCCURRENCE FOR ALL SIMILAR EVENTS ARE IN LINE WITH THIS RISK FILE. THE OVERALL RISK SCORE IS NEGLIGIBLE. CORRECTIVE AND PREVENTIVE ACTIONS: ISSUE EVALUATION (B)(4) HAS BEEN RAISED TO FURTHER INVESTIGATE THIS ISSUE. HEALTH HAZARD EVALUATION (B)(4) HAS BEEN RAISED TO ASSESS THE RISK OF PRODUCT WHICH MAY EXHIBIT THE ISSUE IN THE FIELD. THIS COMPLAINT WAS CONSIDERED AS PART OF THIS HHE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING OPENING OF THE PACKAGING, THE SUPERFICIAL FINAL PAPER LAYER WITH THE ONE UNDERNEATH WAS VISIBLE BAKED PLASTIC PADDING. CATAPULT EFFECT CAN OCCUR WHEN THE PACKAGING IS OPENED AND IT IS HANDED OVER TO THE OPERATING ROOM NURSE. PROSTHESIS HEAD ARE THROWN OUT OF THE PACKAGING. THIS CAN ENDANGER THE ASEPSIS COME.

    Additional Manufacturer Narrative · 1

    (B)(4). FOREIGN REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING OPENING OF THE PACKAGING, THE SUPERFICIAL FINAL PAPER LAYER WITH THE ONE UNDERNEATH WAS VISIBLE BAKED PLASTIC PADDING (DUE TO HEATING DURING STERILIZATION?). "CATAPULT EFFECT" CAN OCCUR WHEN THE PACKAGING IS OPENED AND IT IS HANDED OVER TO THE OPERATING ROOM NURSE. PROSTHESIS HEAD ARE THROWN OUT OF THE PACKAGING. THIS CAN ENDANGER THE ASEPSIS COME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187460 DELTA CER FEM HD 032/0MM 12/14 M 12/14 CERAMIC FEMORAL HEAD PROSTHESIS LZO BIOMET UK LTD. N/A 2019072447

    Patients

    Seq Age Sex Outcome Treatment
    1 Other