BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    FORTE CER FM HD D32/+4MM 12/14 M 12/14

    MDR report key: 9846809 · Received March 18, 2020

    Report

    Report Number
    3002806535-2020-00159
    Event Type
    Malfunction
    Date Received
    March 18, 2020
    Date of Event
    February 21, 2020
    Report Date
    March 31, 2021
    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
    AG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. IN ADDITION, WE HAVE NOT BEEN PROVIDED WITH ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMS NO ABNORMALITIES OR DEVIATIONS REPORTED. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND NO SIMILAR COMPLAINTS REPORTED WITH THE ITEM 164197. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL / FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PACKAGE HAS BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION AND FORWARDED TO THE COMPLAINTS PRODUCT EVALUATION 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. THE SAME IMPLANT WAS USED TO COMPLETE THE SURGERY. THE COMPLAINT HAS BEEN CONFIRMED FOLLOWING REVIEW OF THE RETURNED PACKAGING/PHOTOGRAPHS PROVIDED, WHICH CONFIRMED THE FOAM IS ADHERED TO THE TYVEK LID/THERE IS EVIDENCE OF MATERIAL TRANSFER BETWEEN THE FOAM/TYVEK LID INDICATING THAT THE TOP FOAM HAS BEEN 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 COMPLAINT FOR THE SAME ITEM NUMBER. A COMPLAINT HISTORY REVIEW IDENTIFIED NO SIMILAR COMPLAINTS FOR THE SAME LOT NUMBER. THIS ISSUE IS COVERED BY BOTH THE PACKAGING RISK FILE (INST 4.4.1.9 INPUT OUTPUT RISK TABLE ¿ STERILE DEVICE PACKAGING, REVISION 03) AND THE PROCESS RISK FILE (PFMECA00025 STERILE PACK, REVISION 6). THE SEVERITY OF THE REPORTED EVENT AND THE CALCULATED OCCURRENCE FOR ALL SIMILAR EVENTS IN THE LAST 3 YEARS ARE IN LINE WITH BOTH RISK FILES. 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. HEALTH HAZARD EVALUATION HHE-2020-00082 HAS BEEN RAISED TO ASSESS THE RISK OF PRODUCT WHICH MAY EXHIBIT THE ISSUE IN THE FIELD. THIS HHE RESULTED IN NO FIELD SAFETY CORRECTIVE ACTION. THERE HAS BEEN NO INCREASE IN OCCURRENCE OR SEVERITY SINCE THIS HHE WAS PERFORMED. RISK ASSESSMENT: THIS EVENT OCCURRED DURING SURGERY. NO FURTHER INFORMATION HAS BEEN PROVIDED. THIS GIVES A SEVERITY SCORE OF 2. THE SEVERITY SCORE IS IN LINE WITH THE RISK FILE. OCCURRENCE ASSESSMENT: DATE: 01JAN 2017 TO 28 FEB 2021 (MOST UP TO DATE SALES DATA): (B)(4) NUMBER OF ITEMS SOLD (ITEM NUMBERS: ALL UNITS WITH A TOP FOAM AND TYVEK LID). NUMBER OF COMPLAINTS IDENTIFIED: (B)(4) (INCLUDING THE COMPLAINT (B)(4)). OCCURRENCE RATIO: (B)(4). 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 IN THE LAST 3 YEARS ARE IN LINE WITH BOTH RISK FILES. THE OVERALL RISK SCORE IS NEGLIGIBLE. CORRECTIVE AND PREVENTIVE ACTIONS: HEALTH HAZARD EVALUATION HHE-2020-00082 WAS RAISED TO ASSESS THE RISK OF PRODUCT WHICH MAY EXHIBIT THE ISSUE IN THE FIELD. THIS HHE RESULTED IN NO FIELD SAFETY CORRECTIVE ACTION. THERE HAS BEEN NO INCREASE IN OCCURRENCE OR SEVERITY SINCE THIS HHE WAS PERFORMED. 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 STUCK TO THE LID.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FOAM IN THE PACKAGING STUCK TO THE LID.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT : REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FOAM IN THE PACKAGING STICKS TO THE LID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314569 FORTE CER FM HD D32/+4MM 12/14 M 12/14 HIP PROTHESIS LZO BIOMET UK LTD. N/A 2019050225

    Patients

    Seq Age Sex Outcome Treatment
    1 Other