BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC 133 T1 PPS HO 14X148MM

    MDR report key: 9695817 · Received February 11, 2020

    Report

    Report Number
    0001825034-2020-00638
    Event Type
    Malfunction
    Date Received
    February 11, 2020
    Date of Event
    January 28, 2020
    Report Date
    April 9, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K101086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE RETURNED PRODUCT/PHOTOGRAPHS PROVIDED CONFIRMED THERE IS DEBRIS INSIDE THE STERILE PACKAGING WHICH IS CONSISTENT WITH THE APPEARANCE OF FOAM DEBRIS FROM THE FOAM PACKAGING INSIDE THE STERILE BARRIER. THE REPORTED EVENT IS CONFIRMED AND STERILITY OF THE PRODUCT IS INTACT. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE LIKELY CONDITION OF THE PRODUCT WHEN IT LEFT ZIMMER BIOMET WAS CONFORMING TO SPECIFICATION. THE ROOT CAUSE OF THE REPORTED EVENT IS LIKELY TO BE DUE TO TRANSIT DAMAGE CAUSING THE FOAM PACKAGING TO BECOME ABRADED AND SHED. THE EVENT IS BEING ADDRESSED THROUGH THE CAPA PROCESS. 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 IS AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). UDI#: (B)(4). CONCOMITANT MEDICAL PRODUCTS: TPRLC 133, MP TYPE1 PPS SO 12.0, CAT#51-106120, LOT#3739617. TPRLC 133, MP TYPE1 PPS SO 17.0, CAT#51-106170, LOT#3899164. TPRLC 133, T1 PPS HO 17X154MM, CAT#51-104170, LOT#2441509. TPRLC 133, FP TYPE1 PPS HO 5.0, CAT#51-101050, LOT#3560706. TPRLC 133, FP TYPE1 PPS HO 6.0, CAT#51-101060, LOT#3363703. TPRLC 133, T1 PPS HO 15X150MM, CAT#51-104150, LOT#3564524. TPRLC 133, T1 PPS HO 10X140MM, CAT#51-104100, LOT#3781135. TPRLC 133, MP TYPE1 PPS HO 17.0, CAT#51-107170, LOT#3387034. TPRLC 133, FP TYPE1 PPS SO 5.0, CAT#51-100050, LOT#3262106. TPRLC 133, T1 PPS SO 15X150MM, CAT#51-103150, LOT#3608280. TPRLC 133, T1 PPS SO 17X154MM, CAT#51-103170, LOT#2493026. REPORT SOURCE: (B)(6). 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-00636, 0001825034-2020-00637, 0001825034-2020-00639, 0001825034-2020-00640, 0001825034-2020-00641, 0001825034-2020-00642, 0001825034-2020-00643, 0001825034-2020-00644, 0001825034-2020-00645, 0001825034-2020-00646, 0001825034-2020-00647.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEBRIS WAS FOUND IN STERILE PACKAGING WHILE INVESTIGATING STOCK. 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
    157777 TPRLC 133 T1 PPS HO 14X148MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. NI 3838078

    Patients

    Seq Age Sex Outcome Treatment
    1