BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 RINGLOC ACETEABULAR LINER

    MDR report key: 6572827 · Received May 17, 2017

    Report

    Report Number
    0001825034-2017-03106
    Event Type
    Injury
    Date Received
    May 17, 2017
    Report Date
    January 18, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWL
    PMA / PMN Number
    PK984028
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCT: BIOLOX HEAD, CATALOG#: 650-1056, LOT#: 38719; TAPER SLEVE, CATALOG#: 650-1064, LOT#: 696110; 3-HOLE SHELL, CATALOG#: 13-104148, LOT#: 274870. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    CMP-(B)(4). 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. IMPLANTED APPROXIMATELY 3 YEARS AGO. CONCOMITANT PRODUCTS: CER BIOLOX OPTION HEAD P/N 650-1056 L/N 38719; CER OPTION TAPER SLEEVE P/N 650-1064 L/N 696110; M/H SHELL P/N 13-104148 L/N 27870. REPORT SOURCE: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD A REVISION PROCEDURE THREE YEARS POST-IMPLANTATION DUE TO DISCOMFORT OF THE HIP. THE SURGEON CONFIRMED THE X-RAY AND FOUND THE BREAKAGE OF THE LINER. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353108 E1 RINGLOC ACETEABULAR LINER PROSTHESIS, HIP KWL BIOMET ORTHOPEDICS N/A 862790

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R