BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 PPS LTD ACET SHELL 42A

    MDR report key: 6961197 · Received October 19, 2017

    Report

    Report Number
    0001825034-2017-09143
    Event Type
    Injury
    Date Received
    October 19, 2017
    Date of Event
    December 10, 2015
    Report Date
    October 19, 2017
    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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT:(B)(4). THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. AS PER INVESTIGATION, COMPLAINT IS UNCONFIRMED AS REVIEW OF THE MANUFACTURING HISTORY RECORDS SHOW THE PARTS LEFT ZIMMER BIOMET CONFORMING . THE ROOT CAUSE CANNOT CURRENTLY BE DETERMINED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. DEVICE ANALYSIS INDICATED THAT THE DEVICE MET SPECIFICATION. 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: 0001825034-2015-05196, 0001825034-2015-05196-1, 0001825034-2015-05196-2, 0001825034-2015-05196-3, 0001825034-2015-05195, 0001825034-2015-05195-1, 0001825034-2015-05195-2, 0001825034-2015-05195-3.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY, DURING THE PROCEDURE, TWO LINERS WOULD NOT SEAT INTO THE CUP, CAUSING A THIRTY MINUTE DELAY. ANOTHER CUP AND LINER WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741605 G7 PPS LTD ACET SHELL 42A PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 3094050

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention