BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 NEUTRAL E1 LINER 32MM B

    MDR report key: 8107573 · Received November 27, 2018

    Report

    Report Number
    0001825034-2018-10899
    Event Type
    Injury
    Date Received
    November 27, 2018
    Date of Event
    October 30, 2018
    Report Date
    June 6, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UDI# (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. INSPECTION OF THE RETURNED DEVICE FOUND MULTIPLE FORMS OF MINOR DAMAGE. THE BARB AND SIDEWALL OF THE LINER EXHIBIT INDENTATIONS. THE RIM IS LIGHTLY SCRATCHED. A SMALL SCRATCH WAS ALSO OBSERVED NEAR THE APEX OF THE OUTER RADIUS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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: 010000660 ¿ G7 ACETABULAR SHELL ¿ 6062440. REPORT SOURCE (B)(6). 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2018 -10900.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP PROCEDURE, THE SURGEON HAD DIFFICULTY SEATING THE LINER WITHIN THE CUP. ANOTHER LINER FROM THE SAME LOT ALSO FAILED TO SEAT PROPERLY. FINALLY, A THIRD LINER WAS USED TO COMPLETE THE SURGERY. THERE WAS A DELAY IN THE SURGERY OF OVER 30 MINUTES DUE TO THIS DIFFICULTY. 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
    948145 G7 NEUTRAL E1 LINER 32MM B PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 6065173

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R