BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR-FLEX FEMORAL COMPONENT

    MDR report key: 2100516 · Received May 17, 2011

    Report

    Report Number
    1822565-2011-01184
    Event Type
    Injury
    Date Received
    May 17, 2011
    Report Date
    April 20, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS REC'D FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: MANIPULATION DUE TO POST-OPERATIVE STIFFNESS IS REPORTED. IMPLANT COMPATIBILITY WAS CONFIRMED. X-RAYS WERE NOT PROVIDED. AS SUCH, THE IMPLANT CONSTRUCT CANNOT BE ANALYZED RADIOGRAPHICALLY. BASED ON THE AVAILABLE INFO, AN EXACT CAUSE FOR THE REPORTED CONDITION CANNOT BE DETERMINED. SHOULD ADD'L SUBSTANTIVE INFO REGARDING THE CASE BE REC'D, SUBSEQUENT TO COMPLAINT CLOSURE, THE COMPLAINT WILL BE RE-OPENED AND RE-PROCESSED AT THAT TIME. EVAL: MFG DOCUMENTATION FOR THE REPORTED COMPONENTS HAS BEEN REVIEWED AND INDICATES THE DEVICES WERE MFG, INSPECTED, AND PACKAGED TO SPECIFICATION. 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 REC'D, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT UNDERWENT MANIPULATION FOR POSTOPERATIVE STIFFNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN CR-FLEX FEMORAL COMPONENT MBH ZIMMER, INC. 61131213

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOT # 60598837| NEXGEN TM TIBIAL COMPONENT: CATALOG #00595403701| LOT # 07887401| NEXGEN CR ARTICULAR SURFACE: LOT # 60598837