BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER KNEE

    MDR report key: 3530552 · Received December 12, 2013

    Report

    Report Number
    1822565-2013-01779
    Event Type
    Injury
    Date Received
    December 12, 2013
    Report Date
    November 13, 2013
    Manufacturer
    ZIMMER INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION: PRIMARY OPERATIVE NOTES WERE PROVIDED FOR REVIEW. THE NOTES STATE THAT WITH FINAL COMPONENTS PLACED, THE KNEE HAD EXCELLENT RANGE OF MOTION AND WAS NICELY BALANCED IN FLEXION AND EXTENSION. NO COMPLICATIONS OCCURRED DURING THE PROCEDURE. X-RAYS WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. REHABILITATION PROTOCOL AND ADHERENCE THERETO IS UNKNOWN. NO INFORMATION WAS PROVIDED REGARDING THE IMPLANT THAT IS ALLEGEDLY OUT OF PLACE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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. 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 PATIENT IS EXPERIENCING PAIN, LIMITED MOBILITY, LOOSENING, CRUNCHING NOISE AND IMPLANT IS OUT OF PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650192 UNKNOWN ZIMMER KNEE KNEE PROSTHESIS JWH ZIMMER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other