BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX FEMORAL COMPONENT

    MDR report key: 3110965 · Received May 9, 2013

    Report

    Report Number
    1822565-2013-00776
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    October 22, 2009
    Report Date
    April 9, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    NJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: FIT AND ORIENTATION COULD NOT BE EVALUATED WITHOUT X-RAYS OR SURGICAL NOTES. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL OR TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. EVALUATION: 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 WAS REPORTED THAT THE PATIENT'S KNEE WAS REVISED FOR AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204776 NEXGEN LPS-FLEX FEMORAL COMPONENT NJL ZIMMER, INC. 60856479

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention CATALOG #00598801215, LOT #60795036| NEXGEN STEMMED TIBIAL COMPONENT,| CATALOG #00598003702, LOT #60746389,| NEXGEN STEM EXTENSION,| NEXGEN LPS-FLEX ARTICULAR SURFACE,| CATALOG #00597206532, LOT #60894046,| NEXGEN ALL POLY PATELLA,| MANUFACTURED AT ZIMMER BV, PONCE, PUERTO RICO| CATALOG #00596403012, LOT #60852576| MANUFACTURED AT ZIMMER BV, PONCE, PUERTO RICO