BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER SEGMENTAL SYSTEM ARTICULAR SURFACE

    MDR report key: 1841543 · Received September 14, 2010

    Report

    Report Number
    1822565-2010-00682
    Event Type
    Injury
    Date Received
    September 14, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 17, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT WAS SPECULATED THAT THE BONE FRAGMENTS WERE A RESULT OF A PATIENT FALL AND SUBSEQUENT FRACTURE, WHICH OCCURRED ON (B)(6)2010. THE DEVICE HAD BEEN IMPLANTED FOR APPROXIMATELY 1 YEAR BEFORE THE FALL. PATIENT DEMOGRAPHICS WERE FEMALE, AGE 81, MEDIUM BUILD, OTHER INFORMATION REMAINS UNK. THIRD PARTY WEAR PARTICLES, SUCH AS BONE FRAGMENTS, ARE KNOWN TO BE POTENTIALLY DAMAGING TO ARTICULAR SURFACES. SINCE THE REMOVED ARTICULAR SURFACE WAS NOT RECEIVED, THE SPECIFIC AMOUNT OF DAMAGE CANNOT BE DETERMINED. WITHOUT ADDITIONAL INFORMATION, AN EXACT CAUSE OF THE FAILURE CANNOT BE DETERMINED. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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 INVESTIGATION, 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 WAS REVISED DUE TO THE PRESENCE OF BONE FRAGMENTS PRESENT IN THE SURFACE OF THE ARTICULAR SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER SEGMENTAL SYSTEM ARTICULAR SURFACE KNEE PROSTHESIS JWH ZIMMER, INC. 60824055

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention