BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POS

    MDR report key: 1664694 · Received April 20, 2010

    Report

    Report Number
    1822565-2010-00237
    Event Type
    Injury
    Date Received
    April 20, 2010
    Date of Event
    March 16, 2010
    Report Date
    March 24, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THESE PRODUCTS ARE NOT DESIGNED TO BE USED TOGETHER. REFERENCE THE WARNINGS SECTION OF PACKAGE INSERT 87-6203-453-01 REV I, WHICH WAS PACKAGED WITH 00-5994-032-14 LOT 61294589, FOR DETAILS CONCERNING PRODUCT COMPATIBILITY. THE LIKELY CAUSE OF THE LIMITED RANGE OF MOTION AND PAIN WAS THE INTERFERENCE BETWEEN THE SPINE ON THE ARTICULAR SURFACE AND THE FEMORAL BOX (SPACE BETWEEN CONDYLES). THE PROBABLE CAUSE OF THE REPORTED LIMITED RANGE OF MOTION AND PAIN IS USER ERROR OF UTILIZING INCOMPATIBLE PRODUCTS. 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 ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    PT HAD LIMITED RANGE OF MOTION AND EXPERIENCED PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POS KNEE PROSTHESIS JWH ZIMMER, INC. NA 60804137

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATALOG# 00599403214| SURFACE WITH LOCKING SCREW| KNEE-CONSTRAINED CONDYLAR KNEE (LCCK) ARTICULAR| NEXGEN COMPLETE KNEE SOLUTION LEGACY| LOT# 61294589