BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 NEUTRAL ARCOMXL LNR 36MM H

    MDR report key: 9208376 · Received October 18, 2019

    Report

    Report Number
    0001825034-2019-04737
    Event Type
    Injury
    Date Received
    October 18, 2019
    Date of Event
    September 20, 2019
    Report Date
    January 14, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS UNCONFIRMED. UPON VISUAL INSPECTION THERE IS NO DAMAGE TO THE SHELL. BOTH OF THE RETURNED LINERS SHOWED SCUFFING ON THE OUTSIDE DIAMETER AND DAMAGE TO THE LOCKING FEATURE THAT COULD HAVE CAUSED EVENT. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED DEVIATIONS OR ANOMALIES DURING MANUFACTURING, THE DEVIATIONS OR ANOMALIES WOULD NOT HAVE ATTRIBUTED TO THE EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT BY EMAIL. 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 ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. CONCOMITANT MEDICAL PRODUCTS: PART: 010000668, G7 PPS LTD ACET SHELL 62H, LOT: 3807464. PART: 010000743, G7 NEUTRAL ARCOMXL LNR 36MM H, LOT: 6238012. PART: 010000998, G7 ACETABULAR SCREW, 6.5 X 25 MM, LOT: 6465835. PART: 010000998, G7 ACETABULAR SCREW, 6.5 X 25 MM, LOT: 6242427. PART: 650-1057, 36 HEAD, CERAMIC, LOT: 2958835. PART: 193013, ECHO BIMETRIC MICROPLASTY HIP STEM, LOT: 647390. PART: 650-1066, TAPER ADAPTER, TYPE I, LOT: 2959105. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: CUP: 0001825034-2019-04738. LINER: 0001825034-2019-04736.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INITIAL HIP ARTHROPLASTY THE G7 POLY WOULD NOT ENGAGE INTO THE G7 SHELL, ANOTHER LINER WAS ATTEMPTED AND IT WOULD NOT SEAT AS WELL. SHELL WAS THEN REMOVED AND THE PROCEDURE WAS COMPLETED WITH A SECOND SHELL AND A THIRD LINER. A TOTAL DELAY OF 2.5 HOURS WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000583 G7 NEUTRAL ARCOMXL LNR 36MM H PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 6375903

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR