BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEXGEN LPS-FLEX KNEE

    MDR report key: 3820029 · Received May 14, 2014

    Report

    Report Number
    1822565-2014-00611
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    September 9, 2011
    Report Date
    April 18, 2014
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENT IS UNK. SURGICAL NOTES WERE NOT PROVIDED. RADIOGRAPHS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. HOWEVER, THE COMPLAINT MAY BE REVISED UPON RETURN OF RADIOGRAPHS AND/OR PRODUCT OR FURTHER INFORMATION. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO KNEE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288885 UNKNOWN NEXGEN LPS-FLEX KNEE KNEE PROSTHESIS JWH ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention