BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC 133 MP TYPE1 PPS HO 13.0

    MDR report key: 12533004 · Received September 27, 2021

    Report

    Report Number
    0001825034-2021-02701
    Event Type
    Malfunction
    Date Received
    September 27, 2021
    Date of Event
    September 8, 2021
    Report Date
    November 17, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304513495
    PMA / PMN Number
    K110400
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL EVALUATION OF THE RETURNED PRODUCT IDENTIFIED A VISIBLE HOLE IN THE STERILE POUCH. THE STERILITY, OR BREACH THEREOF, CANNOT BE DETERMINED AS THE PACKAGING BLISTER WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. THE CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET IS CONFORMING TO SPECIFICATION. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO TRANSIT DAMAGE AND A PACKAGING DESIGN ISSUE. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: ITEM # 51-107130 ITEM NAME TPRLC 133 MP TYPE1PPS HO 13.0 LOT# 6945438; ITEM # 51-107130 ITEM NAME TPRLC 133 MP TYPE1PPS HO 13.0 LOT#6971639. PRODUCT HAS BEEN 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 THE PACKAGING FOR THESE STEMS, INSIDE THE BOX, HAS HOLES IN THEM MAKING THE PRODUCT NON STERILE. THE PLASTIC IS FOLDED WHERE IT CREATES HOLES IN THEM AND THE SURGEON WILL NOT USE THEM. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1433970 TPRLC 133 MP TYPE1 PPS HO 13.0 PROSTHETIC, HIP KWA ZIMMER BIOMET, INC. N/A 6974988 00880304513495

    Patients

    Seq Age Sex Outcome Treatment
    1 Male