BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX ARTICULAR SURFACE

    MDR report key: 2041068 · Received March 29, 2011

    Report

    Report Number
    1822565-2011-00770
    Event Type
    Injury
    Date Received
    March 29, 2011
    Report Date
    February 28, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: REVIEW OF THE OPERATION NOTES PROVIDED INDICATES THAT PROPER SURGICAL TECHNIQUE WAS FOLLOWED AND REVIEW OF PRE AND POST OPERATION X-RAYS DO NOT INDICATE ANY ABNORMALITY OF DEVICE IMPLANTATION. PT DEMOGRAPHICS (BUILD, WEIGHT, HEIGHT AND ACTIVITY LEVEL) ARE UNAVAILABLE TO STUDY THE HISTORY. IT IS UNK WHETHER THE CLICKING NOISE IS RELATED TO PATELLAR TRACKING OR RELATED TO LOCKING MECHANISM OF ARTICULAR SURFACE AND TIBIAL BASEPLATE. X-RAYS DO NOT REVEAL ANY DEFORMATION/DAMAGE ON THE PATELLAR/ARTICULAR SURFACE IMPLANTS. WITH THE AVAILABLE INFO, A CONCLUSIVE CAUSE CANNOT BE DETERMINED. 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 AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL 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 HEARS A CLICKING NOISE IN HIS KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS-FLEX ARTICULAR SURFACE JWH ZIMMER, INC. 61615114

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CAT #00597206532, LOT #61582112, MFG AT ZIMMER BV| NEXGEN COMPLETE KNEE SOLUTION ALL POLY PATELLA| PONCE, PUERTO RICO