BEUDAMED
    FDA Adverse Event Other Summary report: N

    NATURAL-KNEE FLEX SYSTEM GENDER SOLUTIONS PROLONG HIGHLY CROSSLINKED POLYETHYLEN

    MDR report key: 1565238 · Received December 22, 2009

    Report

    Report Number
    1822565-2009-01217
    Event Type
    Other
    Date Received
    December 22, 2009
    Date of Event
    November 5, 2009
    Report Date
    November 25, 2009
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    1822565-08/27/2009-001-C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO PRODUCT WAS RETURNED AS IT IS STILL IMPLANTED IN THE PATIENT. ACCORDING TO THE PRODUCT EXPERIENCE REPORT, THE SURGEON WAS UNABLE TO SEAT THE ARTICULAR SURFACE NOT BEING LOCKED APPROPRIATELY TO THE TIBIAL BASEPLATE. BASED ON THE AVAILABLE INFORMATION, THIS MOST LIKELY IS THE CAUSE OF THE CURRENT INCIDENT. EVALUATION: NO PRODUCT WAS RETURNED. 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 DURING SURGERY ON (B)(6) 2009 THE SURGEON WAS UNABLE TO GET THE INSERT LOCKED INTO THE BASEPLATE. THERE WAS A 1MM GAP. DUE TO THERE BEING NO BACKUP OF THIS PRODUCT IN THE HOSPITAL, THE SURGEON LEFT THE DEVICE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL-KNEE FLEX SYSTEM GENDER SOLUTIONS PROLONG HIGHLY CROSSLINKED POLYETHYLEN KNEE PROSTHESIS JWH ZIMMER, INC. NA 61027917

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR