BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 ACETABULAR LINER NEUTRAL 36MM H

    MDR report key: 6061970 · Received October 27, 2016

    Report

    Report Number
    0001825034-2016-04300
    Event Type
    Malfunction
    Date Received
    October 27, 2016
    Date of Event
    September 29, 2016
    Report Date
    July 12, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PBI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. UNIQUE IDENTIFIER (UDI) # - (B)(4). THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-04300 / 04301).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. LINER EXHIBITS DAMAGE TO THE LOCKING RING. A SMALL AMOUNT OF MATERIAL HAS BEEN SCRAPED FROM THE RING AND IS STILL ATTACHED TO THE LINER. THIS DAMAGE LIKELY OCCURRED DURING ATTEMPTED IMPLANTATION AND REMOVAL OF THE LINER. DUE TO THE NATURE OF THE DAMAGE, NO DIMENSIONAL ANALYSIS WILL BE CONDUCTED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTIONS ARE REQUIRED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2016-04300-1, 0001825034-2016-04301-1.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL HIP ARTHROPLASTY, TWO ACETABULAR LINERS WOULD NOT ENGAGE WITH THE CUP AFTER MULTIPLE ATTEMPTS. ANOTHER LINER WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713144 G7 ACETABULAR LINER NEUTRAL 36MM H PROSTHESIS, HIP PBI BIOMET ORTHOPEDICS N/A 3328371

    Patients

    Seq Age Sex Outcome Treatment
    1