BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 OSSEOTI 3 HOLE SHELL 50MM D

    MDR report key: 6955603 · Received October 17, 2017

    Report

    Report Number
    0001825034-2017-09007
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Date of Event
    January 19, 2016
    Report Date
    October 17, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK140669
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET. "ALL OPERATORS MUST BE TRAINED TO VISUAL WORK INSTRUCTION I000052 AND RELEVANT DOCUMENTS. I000052 STATES THE SHRINK WRAPPING MUST BE INSPECTED AFTER COMPLETION TO ENSURE THERE ARE NO HOLES OR SMUDGES ON THE LABEL. REVIEW OF THE MHR CONFIRMS THIS PRODUCT WAS CHECKED AND BOOKED INTO THE STOCKROOM. THE PRODUCT MOST LIKELY LEFT ZIMMER BIOMET CONFORMING BASED ON THIS. THE SHRINK WRAP UTILIZED FOR THIS PRODUCT IS NOT WATERPROOF, AND IF WATER IS EXPOSED TO THE SHRINK WRAP FOR A PERIOD OF TIME WATER DAMAGE CAN OCCUR. THIS DAMAGE MOST LIKELY OCCURRED DURING SHIPMENT OR WHILE AT THE DISTRIBUTORSHIP." REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO DEVIATIONS OR ANOMALIES. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INITIAL TOTAL HIP SURGERY ON (B)(6) 2016, THE PACKAGING OF THE G7 CUP HAD WATER MARKS AND WATER WAS FOUND IN THE PLASTIC WRAP AND ON THE STICKERS. THERE WAS NO PATIENT INVOLVEMENT, BUT THERE WAS A THREE MINUTE DELAY IN THE PROCEDURE. THE PRODUCT WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735684 G7 OSSEOTI 3 HOLE SHELL 50MM D PROTHESIS HIP LPH ZIMMER BIOMET, INC. NI 3632807

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR