BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER KNEE

    MDR report key: 3017080 · Received March 19, 2013

    Report

    Report Number
    1822565-2013-00490
    Event Type
    Injury
    Date Received
    March 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    HRZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A HEALTH PROFESSIONAL WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: REVIEW OF PRIMARY SURGICAL REPORT PROVIDED STATES THAT A "SIZE F NEXGEN POSTERIOR STABILIZED COMPONENT" WAS USED; HOWEVER, THE PART AND LOT NUMBERS OF THE DEVICES ARE UNKNOWN, THUS NOT ALLOWING REVIEW OF COMPLIANCE WITH RECOMMENDED SURGICAL TECHNIQUE. COMMENTS IN THE MRI AND EXAMINATION REPORTS RECEIVED APPEAR CONSISTENT WITH A DETACHED COMPONENT; HOWEVER, NO DEVICES, DEVICE NUMBERS OR PHOTOS WERE RECEIVED TO CONFIRM THIS POSSIBILITY. X-RAYS WERE NOT PROVIDED; THEREFORE, FIT AND ORIENTATION COULD NOT BE EVALUATED. THE SPECIFIC IDENTITY OF THE DEVICE AND THE ROOT CAUSE OF THE REPORTED ISSUE 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'S LEFT KNEE LOCKED UP WHILE WALKING. AN MRI OF THE PATIENT'S KNEE REVEALED A BROKEN POST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114298 UNKNOWN ZIMMER KNEE KNEE PROSTHESIS HRZ ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other