BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTE CER FM HD D32/-4.0 12/14 0MM12/14

    MDR report key: 9693388 · Received February 11, 2020

    Report

    Report Number
    3002806535-2020-00071
    Event Type
    Malfunction
    Date Received
    February 11, 2020
    Date of Event
    January 14, 2020
    Report Date
    June 25, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    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. 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. 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 REPORTED EVENT WAS CONFIRMED THROUGH VISUAL INSPECTION OF THE RETURNED PRODUCT, WHICH IDENTIFIED THAT THE TYVEK LID IS ADHERED TO THE TOP FOAM. 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 ONE SIMILAR COMPLAINT FOR THE SAME ITEM NUMBER, AND NO FURTHER COMPLAINTS FOR THE SAME LOT NUMBER. THE REPORTED EVENT IS DETAILED IN RISK MANAGEMENT FILE INST 4.4.1.9 INPUT OUTPUT RISK TABLE ¿ STERILE DEVICE PACKAGING, REVISION 03. THE ACTUAL SEVERITY AND OCCURRENCE OF THE REPORTED EVENT HAS NOT EXCEEDED THE RECORDED SEVERITY AND OCCURRENCE ON THE RELEVANT LINE IN THE RISK MANAGEMENT FILE. THE LIKELY CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET IS NON-CONFORMING TO SPECIFICATION, HOWEVER, 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 (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. RISK ASSESSMENT: THE RISK ASSOCIATED WITH THE DAMAGED OUTER PACKAGING IS ADDRESSED IN IN INST 4.4.1.9 INPUT OUTPUT RISK. TABLE ¿ STERILE DEVICE PACKAGING, REVISION 03. THE LINE WHICH RELATES TO THIS EVENT IS 5.1.2 - CUSTOMER CANNOT DELIVER PRODUCT INTO THE STERILE FIELD IN A CONTROLLED MANOR. THE SEVERITY SCORE ASSOCIATED WITH THIS FAILURE MODE IS 2 (TEMPORARY OR REVERSIBLE IMPAIRMENT (WITHOUT MEDICAL INTERVENTION)) WITH AN OCCURRENCE SCORE OF 1 (B)(4). SEVERITY ASSESSMENT: THE SEVERITY OF THE COMPLAINTS RECEIVED FROM 03 SEP 2018 (THE END DATE OF THE COMPLAINT SEARCH PERFORMED FOR THE PREVIOUS HHE FOR THE SAME ISSUE) TO 03 MARCH 2020 (TODAY DATE) FOR FOAM ADHERING TO THE TYVEK LID UPON OPENING WAS REVIEWED. THE HIGHEST SEVERITY COMPLAINT RESULTED IN A MODERATE EXTENSION TO SURGERY TIME (S2-TEMPORARY OR REVERSIBLE IMPAIRMENT (WITHOUT MEDICAL INTERVENTION) / TRANSIENT, MINOR IMPAIRMENT OR COMPLAINTS). OCCURRENCE ASSESSMENT: THE OCCURRENCE RATE HAS BEEN CALCULATED USING THE NUMBER OF DEVICES IN THE REPORTED EVENTS ( 34) AND SALES DATA FOR ALL PACKAGING CONFIGURATIONS WITH A TOP FOAM AND A TYVEK LID FROM 01 SEP 2018 TO 31 JAN 2020 (1,824,995). THIS GIVES AN OCCURRENCE RATE OF 1 IN 53,676 (O1). SEE (B)(4). CORRECTIVE AND PREVENTIVE ACTIONS TAKEN: 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. 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 TYVEK LID STUCK TO PRODUCT AND AS A RESULT STERILITY COULD BE COMPROMISED.

    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 THE TYVEK LID STUCK TO PRODUCT AND AS A RESULT STERILITY COULD BE COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160170 FORTE CER FM HD D32/-4.0 12/14 0MM12/14 HIP PROTHESIS JDI BIOMET UK LTD. N/A 2019011931

    Patients

    Seq Age Sex Outcome Treatment
    1 Other