BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN PROLONG LPS-FLEX ARTICULAR SURFACE

    MDR report key: 2980548 · Received February 21, 2013

    Report

    Report Number
    1822565-2013-00365
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    October 28, 2009
    Report Date
    January 25, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF SURGICAL REPORT DATED (B)(6) 2009, DID NOT REVEAL INDICATIONS THAT THE RECOMMENDED SURGICAL TECHNIQUE WAS NOT FOLLOWED. THE ZIMMER STERILIZATION VENDOR PROCESSES ALL IMPLANTS TO MEET FDA REGULATIONS AND ISO STANDARDS AT A STERILITY ASSURANCE LEVEL (SAL) OF 1.0 X 10-6 OR BETTER. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICE CAUSED OR CONTRIBUTED TO ANY PATIENT INFECTION. 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 DUE TO A NON-HEALING WOUND AND POSSIBLE INFECTION. OPEN DEBRIDEMENT, REVISION OF TIBIAL POLYETHYLENE COMPONENT, AND INSERTION OF RESOLVABLE ANTIBIOTIC BEADS WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75065 NEXGEN PROLONG LPS-FLEX ARTICULAR SURFACE JWH ZIMMER, INC. 61291933

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention