BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR FEM STEM PRESS-FIT PLASMA SPRAYED CEMENTLESS

    MDR report key: 10712993 · Received October 21, 2020

    Report

    Report Number
    0001822565-2020-03591
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Date of Event
    September 29, 2020
    Report Date
    March 5, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024132603
    PMA / PMN Number
    K182678
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT WAS CONFIRMED WITH A PHOTOGRAPH OF THE PRODUCT. VISUAL REVIEW IDENTIFIED THE FOLLOWING: THERE WAS A STICKER ON THE M/L TAPER STEM. NO FURTHER EVALUATION IS POSSIBLE USING THE PHOTOGRAPH PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS AND PACKAGING SET UP SHEET IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE ROOT CAUSE CAN BE ATTRIBUTED TO MANUFACTURING DEFICIENCY. A PQS-BWAR-20-0328 WAS ASSIGNED FOR THE REPORTED 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). REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, PRODUCT WAS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT WAS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE DOCTOR OPENED THE PACKAGE AND NOTICED THAT THERE WAS A STICKER STICKING ON M/L KINECTIV STEM. 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
    1178656 MODULAR FEM STEM PRESS-FIT PLASMA SPRAYED CEMENTLESS PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 64602696 00889024132603

    Patients

    Seq Age Sex Outcome Treatment
    1