BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC 133 T1 PPS SO 17X154MM T1

    MDR report key: 10854085 · Received November 17, 2020

    Report

    Report Number
    0001825034-2020-04119
    Event Type
    Malfunction
    Date Received
    November 17, 2020
    Date of Event
    October 27, 2020
    Report Date
    December 4, 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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY EVALUATION OF THE RETURNED PRODUCT/PHOTOGRAPHS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE EVENT WERE FOUND. THE ROOT CAUSE OF THE REPORTED EVENT IT LIKELY TO BE DAMAGE DURING TRANSIT. EVALUATION OF THE RETURNED PRODUCT/PHOTOGRAPHS PROVIDED CONFIRMED THE FOLLOWING: LOT #3873636 : DAMAGE TO STERILE POUCH AND DEBRIS INSIDE THE STERILE PACKAGING WHICH IS CONSISTENT WITH THE APPEARANCE OF THE POROUS COATING. LOT #3873652 DAMAGE TO STERILE BLISTER AND DEBRIS INSIDE THE STERILE PACKAGING WHICH IS CONSISTENT WITH THE APPEARANCE OF FOAM DEBRIS FROM THE FOAM PACKAGING AND THE POROUS COATING INSIDE THE STERILE BARRIER. FURTHER EVALUATION FOUND THE OUTER CARTON TO BE DAMAGED. THE PRODUCTS WERE RETURNED OPENED. THE STERILITY OF THE DEVICES CANNOT BE DETERMINED. THE LIKELY CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET IS CONFORMING TO SPECIFICATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 04120.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TOTAL HIP ARTHROPLASTY THE SURGICAL TECH BEGAN OPENING THE PACKAGING FOR THE STEM, THERE WAS BLACK RESIDUE AT BOTH ENDS OF THE STEM AND THE PACKAGING HAD A SMALL OPENING AT THE DISTAL END OF THE STEM. . TOTAL DELAY OF THE SURGERY WAS AN ESTIMATED 20-25 MINUTES. NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320343 TPRLC 133 T1 PPS SO 17X154MM T1 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 3873636

    Patients

    Seq Age Sex Outcome Treatment
    1