BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSALL/BURSTEIN II MODULAR KNEE SYSTEM POSTERIOR STABILIZED CONDYLAR SERIES

    MDR report key: 1181603 · Received September 29, 2008

    Report

    Report Number
    1822565-2008-00660
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    August 5, 2008
    Report Date
    August 15, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO PRODUCT RETURNED FOR EVALUATION. ALSO, X-RAYS ARE NOT AVAILABLE FOR REVIEW. THE CAUSE OF THE REPORTED PROBLEM OF POLYETHYLENE WEAR COULD NOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION HOWEVER, THE HIGH ACTIVITY LEVEL OF THE PATIENT COULD BE A CONTRIBUTING FACTOR. H6: EVALUATION: 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 CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 1999. THE DEVICE WAS REVISED IN 2008, DUE TO POLYETHYLENE LINER WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSALL/BURSTEIN II MODULAR KNEE SYSTEM POSTERIOR STABILIZED CONDYLAR SERIES KNEE PROSTHESIS JWH ZIMMER, INC. NA 34409300

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R