BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC 133 FP TYPE1 PPS SO 5.0

    MDR report key: 10024625 · Received May 5, 2020

    Report

    Report Number
    0001825034-2020-01913
    Event Type
    Malfunction
    Date Received
    May 5, 2020
    Date of Event
    April 24, 2020
    Report Date
    July 14, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K101086
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. EVALUATION OF THE RETURNED PRODUCTS CONFIRMS THE STERILE PACKAGING (BLISTER AND FOAM) IS DAMAGED AND THERE IS DEBRIS INSIDE THE STERILE PACKAGING WHICH IS CONSISTENT WITH THE APPEARANCE OF FOAM DEBRIS FROM THE FOAM PACKAGING INSIDE THE STERILE BARRIER. THEREFORE, THE REPORTED EVENT IS CONFIRMED. STERILITY WAS NOT COMPROMISED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THESE PRODUCTS WERE LIKELY CONFORMING WHEN THEY LEFT ZIMMER BIOMET CONTROL. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO TRANSIT DAMAGE CAUSING THE POROUS COATING TO SHED FROM THE IMPLANT. THIS DEVICE FALLS WITHIN THE SCOPE OF A CORRECTIVE ACTION WHICH IS TO ASSESS ALL CURRENT STERILE BARRIER SYSTEMS USED TO PACKAGE PRODUCTS AT ZIMMER BIOMET BRIDGEND. AS PART OF THIS CORRECTIVE ACTION, THE POUCH IS BEING IMPROVED TO USE A STRONGER MATERIAL (NYLON), AND FOAM END CAPS ARE BEING ADDED. ALSO, THE ORIENTATION THE DEVICES ARE PACKED IN THE SHIPPER BOX IS MOVING FROM VERTICAL TO HORIZONTAL, AND THE THICKNESS OF THE SHIPPER BOX HAS BEEN INCREASED. UPON INVESTIGATION, IT HAS BEEN DETERMINED THAT THE DEBRIS IN THE STERILE PACKAGING MEETS THE ACCEPTABLE CRITERIA AND PRODUCT IS CONFORMING TO SPECIFICATIONS. EVENT IS NO LONGER CONSIDERED REPORTABLE, AND INITIAL REPORT SHOULD BE VOIDED 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

    UPON INVESTIGATION, IT HAS BEEN DETERMINED THAT THE DEBRIS IN THE STERILE PACKAGING MEETS THE ACCEPTABLE CRITERIA AND PRODUCT IS CONFORMING TO SPECIFICATIONS. EVENT IS NO LONGER CONSIDERED REPORTABLE, AND INITIAL REPORT SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: FOREIGN (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-01908, 0001825034-2020-01909, 0001825034-2020-01910, 0001825034-2020-01911, 0001825034-2020-01912. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS DEBRIS IN THE STERILE PACKAGING. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490829 TPRLC 133 FP TYPE1 PPS SO 5.0 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 2815569

    Patients

    Seq Age Sex Outcome Treatment
    1