BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR PROLONG ARTICULAR SURFACE

    MDR report key: 3820015 · Received May 14, 2014

    Report

    Report Number
    1822565-2014-00609
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    March 16, 2012
    Report Date
    April 16, 2014
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT LABELS INDICATE THAT PT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6), 2011. PT LABELS ALSO INDICATE THAT THE PT UNDERWENT A REVISION SURGERY ON (B)(6), 2012 DURING WHICH ONLY THE ARTICULAR SURFACE WAS REPLACED. REVIEW OF THE RETURNED RADIOLOGY REPORTS AND RADIOGRAPHS DOES NOT INDICATE ROOT CAUSE. REVIEW OF THE RETURNED PHOTOGRAPHS OF THE EXPLANTED ARTICULAR SURFACE DOES NOT INDICATE ROOT CAUSE. WEAR ON THE ARTICULATING SURFACE CANNOT BE IDENTIFIED DUE TO THE QUALITY OF THE PHOTOGRAPHS. THERE APPEARS TO BE GOUGING TO THE UNDERSIDE OF THE ARTICULAR SURFACE AT THE POSTERIOR ASPECT OF THE MEDIAL CONDYLE; HOWEVER, THIS COULD BE GLARE DUE TO THE ANGLE AT WHICH THE PHOTOGRAPH WAS TAKEN. THERE ARE NO INDICATIONS OF BACKSIDE WEAR. THE EXPLANTED COMPONENT AND SURGICAL NOTES WERE NOT RETURNED FOR REVIEW. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. HOWEVER, THE COMPLAINT MAY BE REVISED UPON RETURN OF PRODUCT, SURGICAL NOTES, OR FURTHER INFORMATION. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE PAIN AND POSSIBLE TORQUE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289065 NEXGEN CR PROLONG ARTICULAR SURFACE JWH ZIMMER INC 61755340

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention