BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 ACETABULAR LINER

    MDR report key: 6539913 · Received May 3, 2017

    Report

    Report Number
    0001825034-2017-02988
    Event Type
    Malfunction
    Date Received
    May 3, 2017
    Date of Event
    April 6, 2017
    Report Date
    February 5, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED REVEALED LINER LOCKING FEATURE HAS MINOR DAMAGE AND IS DENTED AND NICKED IN SEVERAL PLACES AROUND THE ENTIRE CIRCUMFERENCE OF THE PART. INSPECTION OF THE OUTER RADIUS OF THE PART REVEALS SOME MINOR SCRATCHING DISTRIBUTED AROUND THE ENTIRE PART. INTERIOR OF THE LINER SHOWS SOME MINOR SCRATCHING AS WELL. SEVERAL OF THE SCALLOPS SHOW DAMAGE. DIMENSIONAL ANALYSIS WILL NOT BE DONE DUE TO THE ABOVE LISTED DAMAGE. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - 28 MM DIA COCR MOD HD +9 MM NK/ PN 163665/ LN 902610, ACT ARTIC E1 HIP BRG 28 X 46 MM/ PN EP-200152/ LN 131870, G7 OSSEOTI MULTIHOLE 68 MM I/ PN 110010272/ LN 3939638. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION DUE TO DISLOCATION. THE FREEDOM LINER WOULD NOT SEAT INTO THE CUP. THE SURGEON TRIED 10 TIMES TO IMPLANT THE LINER BUT IT WOULD NOT ENGAGE. NO DELAY OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322712 G7 ACETABULAR LINER PROSTHESIS, HIP PBI BIOMET ORTHOPEDICS N/A 3471600

    Patients

    Seq Age Sex Outcome Treatment
    1