BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS FEMORAL COMPONENT

    MDR report key: 2041109 · Received March 29, 2011

    Report

    Report Number
    1822565-2011-00772
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    August 17, 2010
    Report Date
    March 1, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: IMPLANT COMPATIBILITY WAS CONFIRMED. NEITHER X-RAYS NOR OP-NOTES WERE PROVIDED. AS SUCH, SURGICAL TECHNIQUE CANNOT BE REVIEWED AND THE IMPLANT CONSTRUCT CANNOT BE ANALYZED RADIOGRAPHICALLY. PT DEMOGRAPHICS WERE NOT PROVIDED. BASED ON THE AVAILABLE INFO, THE CAUSE OF THE REPORTED PAIN CANNOT BE DETERMINED. MFG RECORDS FOR THE REPORTED DEVICES WERE REVIEWED AND INDICATE THEY WERE MFG, INSPECTED, AND PACKAGED TO SPECIFICATION. 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 INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS FEMORAL COMPONENT JWH ZIMMER, INC. 61244015

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOT #61203719 MFR BY ZIMMER B.V.| NEXGEN STEMMED NONAUGMENTABLE TIBIAL COMPONENT| CAT #00596404012, LOT #61217492| NEXGEN LPS-FLEX ARTICULAR SURFACE| NEXGEN ALL POLY PATELLA: CAT #00597206538| PONCE, PUERTO RICO| CAT #00598604702, LOT #61207424 MFR BY ZIMMER B.V.