BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 ACETABULAR LINER

    MDR report key: 6772210 · Received August 7, 2017

    Report

    Report Number
    0001825034-2017-05840
    Event Type
    Malfunction
    Date Received
    August 7, 2017
    Date of Event
    June 23, 2017
    Report Date
    April 6, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PBI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. TWO (2) G7 HI-WALL ARCOMXL LNR 36MM F WITH PART # 010000819 FROM LOT 3955788 WERE RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION FOUND DAMAGE COMMON TO BOTH LINERS. THE BARBS ARE SCRAPED SUCH THAT A POLY STRAND PROTRUDES FROM THE LINER. THE SIDE WALLS ARE GOUGED. THE SCALLOPS OF THE ELEVATED PORTION OF THE LINERS ARE DEFORMED FROM MAKING CONTACT WITH THE SHELL AT THE TIME OF IMPACTION. ONE LINER SHOWS AN INDENTATION ON THE OUTER RADIUS LIKELY CAUSED BY MAKING CONTACT WITH A SCREW THAT WAS NOT SEATED PROPERLY IN THE SHELL. THE OUTER RADIUS OF THE OTHER LINER WAS FREE OF ANY DAMAGE. DIMENSION ANALYSIS WAS NOT POSSIBLE BECAUSE OF THE IMPACT ON THE LINERS. THE LIKELY CONDITION OF THE PRODUCT IS CONFORMING WHEN IT LEFT ZIMMER BIOMET. DHR 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-05840, 0001825034-2018-02424.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON COULD NOT SUCCESSFULLY IMPACT POLY INSERT. THE SURGICAL TECHNIQUE WAS FOLLOWED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551327 G7 ACETABULAR LINER HIP PROSTHESIS PBI BIOMET ORTHOPEDICS N/A 3955788

    Patients

    Seq Age Sex Outcome Treatment
    1