BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LPS-FLEX ARTICULAR SURFACE

    MDR report key: 2080977 · Received April 13, 2011

    Report

    Report Number
    1822565-2011-00940
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 17, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: THE DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND NO BLACK SMEAR COULD BE IDENTIFIED. THE COMPLAINT HISTORY FOR THIS LOT WAS REVIEWED AND NO ADDITIONAL COMPLAINTS HAVE BEEN RECEIVED. WITHOUT FURTHER INFORMATION, THE COMPLAINT ALLEGATION CANNOT BE CONFIRMED. 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 IS REPORTED THAT THE IMPLANT HAD A BLACK SMEAR ON IT. THE SURGEON DID NOT NOTICE UNTIL HE STARTED TO IMPLANT IT IN THE PATIENT. AFTER NOTICING IT, HE HANDED IT TO THE HOSPITAL PERSONNEL AND IMPLANTED ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS-FLEX ARTICULAR SURFACE JWH ZIMMER INC 61678793

    Patients

    Seq Age Sex Outcome Treatment
    1