BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVITAN, DISTAL PART, CURVED, UNCEMENTED, 20/200

    MDR report key: 8334914 · Received February 13, 2019

    Report

    Report Number
    0009613350-2019-00063
    Event Type
    Malfunction
    Date Received
    February 13, 2019
    Date of Event
    January 16, 2019
    Report Date
    June 26, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CORRECTION:DATE OF REPORT, PMA/510K. ADDITIONAL: CONCOMITANT MEDICAL PRODUCTS, IF FOLLOW-UP, WHAT TYPE. DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: INNER (STERILE) PACKAGING DEFECT. EVENT SUMMARY: IT WAS REPORTED THAT UPON OPENING IMPLANT, OR PERSONNEL NOTICED THAT ALL THE PLASTIC BAGS CONTAINING IMPLANT WERE COMPROMISED. REVIEW OF RECEIVED DATA - NO CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS - THE VISUAL EXAMINATION SHOWS THAT IN THE 2 INNER LAYERS THE BAGS HAVE A RIP EXACTLY AT THE AREA WHERE THE BAGS WERE FOLDED. THIS HOLE IS AT THE PROXIMAL END POSITION OF THE STEM. THE PROTECTION CAP IS COMPLETELY BROKEN. IT IS NOT VISIBLE IF THE STEM PIERCED ALSO TROUGH THE OUTER BAG. FURTHER, NO CONSPICUOUSNESS COULD BE IDENTIFIED. BASED ON THIS VISUAL EXAMINATION THE REPORTED EVENT CAN BE CONFIRMED. CONCLUSION SUMMARY IT WAS REPORTED THAT UPON OPENING IMPLANT, OR PERSONNEL NOTICED THAT ALL THE PLASTIC BAGS CONTAINING IMPLANT WERE COMPROMISED. THE VISUAL EXAMINATION SHOWS THAT IN THE 2 INNER LAYERS THE BAGS HAVE A RIP EXACTLY AT THE AREA WHERE THE BAGS WERE FOLDED. THIS HOLE IS AT THE PROXIMAL END POSITION OF THE STEM. THE PROTECTION CAP IS COMPLETELY BROKEN. IT IS NOT VISIBLE IF THE STEM PIERCED ALSO TROUGH THE OUTER BAG. THE DEVICE MANUFACTURING QUALITY RECORDS WERE CHECKED AND INDICATES THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. WE COULD EXCLUDE THAT THE PACKAGE DAMAGE OCCURRED DURING THE PACKAGING PROCESS AND THEREFORE IT CAN BE CONCLUDED THAT A WRONG HANDLING OR TRANSPORTATION ISSUE OF THE DEVICE HAS MOST LIKELY LED TO THE DAMAGED PACKAGING. THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). HOWEVER, A BIG SCOPE OF PACKAGING CONFIGURATIONS WERE CHANGED IN THE YEAR 2017 TO OPTIMIZE THE DESIGN. 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

    NO CHANGE TO PREVIOUSLY REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K071723. THE MANUFACTURER DID NOT RECEIVE THE DEVICE YET, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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 UPON OPENING REVITAN DISTAL IMPLANT, OR PERSONNEL NOTICED THAT ALL THE PLASTIC BAGS CONTAINING THE IMPLANT WERE COMPROMISED. SURGERY WAS COMPLETED WITH ANOTHER DEVICE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE HOWEVER NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127352 REVITAN, DISTAL PART, CURVED, UNCEMENTED, 20/200 N/A KWA ZIMMER GMBH N/A 2756148

    Patients

    Seq Age Sex Outcome Treatment
    1