BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC XR T1 PPS 14X148MM MM T1

    MDR report key: 11448061 · Received March 9, 2021

    Report

    Report Number
    0001825034-2021-00687
    Event Type
    Malfunction
    Date Received
    March 9, 2021
    Date of Event
    February 17, 2021
    Report Date
    April 9, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K120030
    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. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: D4; D9; G3; H2; H3; H4; H6 COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. EVALUATION OF THE RETURNED PRODUCT/PHOTOGRAPHS PROVIDED CONFIRMED THE FOLLOWING: 3595176: STERILE PACKAGING BLISTER IS DAMAGED. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO TRANSIT DAMAGE AND PACKAGING DESIGN DEFICIENCY. THE EVENT IS BEING ADDRESSED THROUGH THE CAPA PROCESS THE DEVICE EVALUATION FOUND THE PRODUCT TO BE CONFORMING AND STERILITY NOT COMPROMISED. FURTHER, THE EVENT DID NOT CONTRIBUTE TO A SERIOUS INJURY; THEREFORE, THIS WOULD NOT BE CONSIDERED A REPORTABLE EVENT. 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). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN THE PROCESS OF BEING RETURNED TO ZIMMER BIOMET. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM # 51-105150/ TPRLC XR T1 PPS / LOT # 6222403, ITEM# 51-104150/TPRLC 133 T1 PPS HO/ LOT #3838103. REPORT SOURCE: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2021 -00684. 0001825034 -2021 -00685.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INVESTIGATION OF PRODUCT AT THE DISTRIBUTORSHIP, DEBRIS WAS FOUND INSIDE THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. 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
    343079 TPRLC XR T1 PPS 14X148MM MM T1 PROSTHESIS HIP JDI ZIMMER BIOMET, INC. NI 3595176

    Patients

    Seq Age Sex Outcome Treatment
    1