BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 PPS LTD ACET SHELL 58G

    MDR report key: 7951502 · Received October 10, 2018

    Report

    Report Number
    0001825034-2018-09557
    Event Type
    Injury
    Date Received
    October 10, 2018
    Date of Event
    September 11, 2018
    Report Date
    February 20, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UDI # ((B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE COMPLAINT WAS NOT CONFIRMED. 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 NEUTRAL ARCOMXL LNR 36MM G, PN 010000742, LN 3822626. G7 NEUTRAL ARCOMXL LNR 40MM G, PN 010000748, LN 3387335. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034-2018-09558, 0001825034-2018-09559. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 LINER WOULD NOT SEAT PROPERLY INTO A CUP AFTER SEVERAL ATTEMPTS. DUE TO REMOVING ORIGINAL CUP AND RE-IMPLANTING DIFFERENT CUP, CLEANING AND EXPOSING TISSUE, MULTIPLE ATTEMPTS AT SEATING, AND LINERS BEING DIFFICULT TO INSERT, THERE WAS A 45 MINUTE DELAY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792095 G7 PPS LTD ACET SHELL 58G PROSTHESIS HIP PBI ZIMMER BIOMET, INC. N/A 6124028

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R