BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXFORD UNI TWIN-PEG FEMORAL XS

    MDR report key: 9863313 · Received March 21, 2020

    Report

    Report Number
    3002806535-2020-00162
    Event Type
    Malfunction
    Date Received
    March 21, 2020
    Date of Event
    February 24, 2020
    Report Date
    June 16, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    P010014
    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. G3: REPORT SOURCE, FOREIGN - EVENT OCCURRED IN GERMANY. PRODUCTS HAVE BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION AND FORWARDED TO THE PRODUCT EVALUATION COMPLAINTS ENGINEER FOR INVESTIGATION. SUMMARY OF INVESTIGATION: THE EVENT REPORTS THAT IT WAS IDENTIFIED THAT THAT THE TOP FOAM WAS ADHERED TO THE TYVEK LID. THIS EVENT OCCURRED DURING 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 NO SIMILAR COMPLAINTS FOR THE SAME ITEM NUMBER. A COMPLAINT HISTORY REVIEW IDENTIFIED NO SIMILAR COMPLAINTS FOR THE SAME LOT NUMBER. 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. 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. ISSUE EVALUATION IE-11839 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. RISK ASSESSMENT: SEVERITY ASSESSMENT: (B)(4). -THIS EVENT OCCURRED DURING SURGERY. NO FURTHER INFORMATION HAS BEEN PROVIDED. -THE SEVERITY SCORE IS IN LINE WITH THE RISK FILE. OCCURRENCE ASSESSMENT: -(B)(4). THIS GIVES AN OCCURRENCE SCORE OF 1. RISK SCORE: -S2 X O1 ¿ RPN 2 (NEGLIGIBLE). RISK ASSESSMENT SUMMARY: 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. 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 THE FOAM IN THE PACKAGING STICKS TO THE LID. NO DELAY REPORTED. NO PATIENT, USER, OR OTHER STAKEHOLDER HARM.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 THE FOAM STICKING TO TYVEK LID. THERE WAS NO DELAY OF THE PROCEDURE. NOT KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT OR THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326771 OXFORD UNI TWIN-PEG FEMORAL XS UNICONDYLAR KNEE PROSTHESIS NRA BIOMET UK LTD. N/A J6595352

    Patients

    Seq Age Sex Outcome Treatment
    1