BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER PERIARTICULAR LOCKING TIBIAL PLATE

    MDR report key: 2251520 · Received September 14, 2011

    Report

    Report Number
    1822565-2011-02070
    Event Type
    Injury
    Date Received
    September 14, 2011
    Date of Event
    August 26, 2009
    Report Date
    August 17, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: IF THE BONE WAS NOT PROPERLY REDUCED DURING SURGERY, OR IF THE PT WAS NONCOMPLIANT OR HAD POOR BONE QUALITY, NON-UNION MIGHT HAVE TAKEN PLACE. NO PRODUCT WAS RETURNED FOR FURTHER EVAL TO DETERMINE MODE OF FAILURE. BASED ON INFO PROVIDED IN THE COMPLAINT POCKET, A LIKELY ROOT CAUSE OF THE PLATE BREAKING CANNOT BE DETERMINED. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. 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 ADD'L 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 PT WAS REVISED AFTER THE PLATE FRACTURE DONE (B)(6) 2009. A ROD WAS IMPLANTED AT REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER PERIARTICULAR LOCKING TIBIAL PLATE HRS ZIMMER, INC. 60784935

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention