BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER KNEE

    MDR report key: 4092250 · Received August 20, 2014

    Report

    Report Number
    1822565-2014-01006
    Event Type
    Injury
    Date Received
    August 20, 2014
    Report Date
    July 22, 2014
    Manufacturer
    ZIMMER, INC
    Product Code
    JWH
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION, THERE IS NO ALLEGED EVENT AGAINST A ZIMMER BIOMET PRODUCT. THE PRODUCT IS MANUFACTURED BY A COMPETITOR.

    Additional Manufacturer Narrative · 1

    SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. CAUSE CANNOT BE DEFINITIVELY DETERMINED. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBER 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. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT IS EXPERIENCING PAIN AND DIFFICULTY REGAINING RANGE OF MOTION. THE PT UNDERWENT A MANIPULATION ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500679 UNKNOWN ZIMMER KNEE KNEE PROSTHESIS JWH ZIMMER, INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other