BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCOS CON SZ B STD 60MM HA

    MDR report key: 6631018 · Received June 9, 2017

    Report

    Report Number
    0001825034-2017-03779
    Event Type
    Malfunction
    Date Received
    June 9, 2017
    Date of Event
    May 17, 2017
    Report Date
    October 11, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PNA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. CONCOMITANT PRODUCTS - 22-300917 STRAIGHT TAPERED SPLINED DISTAL STEM 047070. (B)(6).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. DEVICES WERE EVALUATED UPON RECEIVING. THE STEM WAS FREE FROM ANY DAMAGE. THE TAPER WAS ALSO FREE FROM DAMAGE WITH THE EXCEPTION OF SCRATCHES AROUND THE TOP OF THE TAPER WHERE THE SCREW CAN BE INSERTED. THE SCREW HOLDING THE DEVICES TOGETHER IS STRIPPED. THE SCREW COULD NOT BE REMOVED BY BEING HAND TORQUED WITH A STANDARD SET OF ALLEN WRENCHES. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BODY WAS IMPLANTED ONTO THE STEM AND THE LOCKING SCREW WAS INSERTED BUT NEVER FELT RIGHT AND NEVER TORQUED CORRECTLY CAUSING THE HEAD TO ROUND OFF. A TWENTY MINUTE DELAY WAS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410018 ARCOS CON SZ B STD 60MM HA PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 058930

    Patients

    Seq Age Sex Outcome Treatment
    1 Other