BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 HI-WALL E1 LINER 40MM H

    MDR report key: 9586041 · Received January 14, 2020

    Report

    Report Number
    0001825034-2020-00198
    Event Type
    Malfunction
    Date Received
    January 14, 2020
    Date of Event
    December 10, 2019
    Report Date
    May 13, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWZ
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED DEVICE WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION FOUND MULTIPLE FORMS OF DAMAGE. SCRATCHES WERE OBSERVED ON THE OUTER RADIUS. HEAVIER GOUGES AND INDENTATIONS WERE OBSERVED ON THE SIDEWALL AND RIM OF THE LINER. THE OUTER RADIUS DID NOT EXHIBIT ANY SIGNS OF COMING IN CONTACT OF FOREIGN OBJECTS DURING IMPACTION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO 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). CONCOMITANT MEDICAL PRODUCTS: G7 HI-WALL E1 LINER 40MM H, PN 010000944, LN 3882097. UNKNOWN CUP, PN UNKNOWN, LN UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-00197. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LINERS WOULD NOT FIT INTO THE CUP. THE SURGEON SWITCHED TO A NEUTRAL LINER TO FINISH THE PROCEDURE. THIS CAUSED A DELAY OF ABOUT 20 MINUTES. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52467 G7 HI-WALL E1 LINER 40MM H PROSTHESIS, HIP KWZ ZIMMER BIOMET, INC. N/A 6569646

    Patients

    Seq Age Sex Outcome Treatment
    1