BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LCCK FEMORAL COMPONENT

    MDR report key: 2890782 · Received December 21, 2012

    Report

    Report Number
    1822565-2012-02581
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    January 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NEITHER SURGICAL NOTES NOR X-RAYS WERE PROVIDED, THEREFORE, FIT AND ORIENTATION COULD NOT BE EVALUATED. 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 PT INFECTION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. EVALUATION: MANUFACTURING DOCUMENTATION WAS REVIEWED AND INDICATES THAT THE DEVICE WAS MANUFACTURED, INSPECTED, AND PACKAGED TO SPECIFICATION. IF THE REPORTED IMPLANT DATE FOR 00-5994-030-12, LOT 60035380 IS CORRECT, THEN THE DEVICE WAS PAST THE SHELF LIFE DATE. 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO INFECTION. IT IS ALSO REPORTED THAT THE PT UNDERWENT MULTIPLE FLUID AND DEBRIS REMOVAL TREATMENTS ON UNKNOWN DATES IN 2011. THE PT DEVELOPED A STAPH INFECTION FROM DEBRIS THAT HAD PASSED THROUGH THE PT'S BLOOD STREAM DUE TO FRICTION FROM THE FEMORAL COMPONENT AND THE PT'S TENDON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LCCK FEMORAL COMPONENT JWH ZIMMER, INC. 60070635

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATALOG #00599403012, LOT #60035380| CATALOG #00598801112, LOT #61314521, MANUFACTURED| CATALOG #00598802012, LOT #41821200| AT ZIMMER BV, PONCE, PUERTO RICO.| NEXGEN STEMMED TIBIAL COMPONENT:| ALL OF THE ABOVE PRODUCTS WERE IMPLANTED:| CATALOG #00598800300, LOT #61663829| NEXGEN LCCK ARTICULAR SURFACE:| NEXGEN FEMORAL AUGMENT BLOCK:| NEXGEN OFFSET STEM EXTENSION:| NEXGEN STEM EXTENSION STRAIGHT:| CATALOG #00599003324, LOT #5617980