BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC 133 MP TYPE1 PPS SO 15.0

    MDR report key: 12318730 · Received August 13, 2021

    Report

    Report Number
    0001825034-2021-02403
    Event Type
    Malfunction
    Date Received
    August 13, 2021
    Date of Event
    July 17, 2021
    Report Date
    August 31, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWZ
    UDI-DI
    00880204514379
    PMA / PMN Number
    K110400
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: G3; H2; H3; H6. EVALUATION OF THE RETURNED PRODUCT CONFIRMED THERE IS DEBRIS INSIDE THE STERILE PACKAGING WHICH IS CONSISTENT WITH THE APPEARANCE OF POROUS COATING. THE STERILE POUCH HAS LOST ITS VACUUM SEAL AND SCUFF MARKS WERE FOUND INSIDE THE POUCH. RED/BROWN DEBRIS/STAINS WERE FOUND ON THE POUCH WHICH ARE CONSISTENT WITH SURGICAL DEBRIS AND IS NOT CONSIDERED A PRODUCT FAILURE. THE STERILITY, OR BREACH THEREOF, CANNOT BE DETERMINED AS THE BLISTER WAS NOT RETURNED FOR EVALUATION. THE REPORTED EVENT IS CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. 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). 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. CONCOMITANT MEDICAL DEVICES: ITEM # 51-106150/ TPRLC 133 MP TYPE1 PPS/ LOT # 6912739; ITEM # 51-106150/ TPRLC 133 MP TYPE1 PPS / LOT # 6966588. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2021 -02402, 0001825034 -2021 -02404.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INITIAL HIP PROCEDURE THE TAPERLOC STEMS PACKAGING WAS DAMAGED AND BLACK DEBRIS WAS FOUND IN STERILE PACKAGING. NO SURGICAL DELAY WAS NOTED. 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
    1217098 TPRLC 133 MP TYPE1 PPS SO 15.0 PROSTHESIS HIP KWZ ZIMMER BIOMET, INC. NI 6912739 00880204514379

    Patients

    Seq Age Sex Outcome Treatment
    1