BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN PROLONG LPS-FLEX ARTICULAR SURFACE

    MDR report key: 1940535 · Received December 21, 2010

    Report

    Report Number
    1822565-2010-01424
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    February 17, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE REASON FOR INSTABILITY/LAXITY IS UNK. REVIEW OF SURGICAL NOTES PROVIDED INDICATES THAT PROPER SURGICAL TECHNIQUE WAS FOLLOWED. THERE ARE NO RETURNED PRODUCTS OR X-RAYS AVAILABLE TO STUDY THE IMPLANTATION TECHNIQUE. WITHOUT FURTHER INFO ON THE SURGERY AND/OR RETURN OF PRODUCT/X-RAYS, A PROBABLE CAUSE FOR ALLEGED DEFICIENCY CANNOT BE DETERMINED. EVAL: 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 INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE POLY LINER WAS EXCHANGED TO IMPROVE MEDIAL AND LATERAL STABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN PROLONG LPS-FLEX ARTICULAR SURFACE KNEE PROSTHESIS JWH ZIMMER, INC. 60290935

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention