BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER ARTICULAR SURFACE

    MDR report key: 2971867 · Received February 19, 2013

    Report

    Report Number
    1822565-2013-00337
    Event Type
    Injury
    Date Received
    February 19, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    HRZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS RETURNED, THE ARTICULAR SURFACE EXHIBITS A FRACTURED POST. ALSO PITTING AND WEAR IS PRESENT ON THE BACK SIDE AND CONDYLE CONTACT PADS. NEITHER SURGICAL NOTES NOR X-RAYS WERE PROVIDED; THEREFORE, FIT AND ORIENTATION COULD NOT BE EVALUATED. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL OR TYPE OF ACTIVITY (LOW IMPACT VS HIGH IMPACT) ARE UNK. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS WERE 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 INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE POST OF THE ARTICULAR SURFACE FRACTURED OFF. AS A RESULT, THE PT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72763 UNKNOWN ZIMMER ARTICULAR SURFACE KNEE PROSTHESIS HRZ ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention