BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX FEMORAL COMPONENT

    MDR report key: 2546612 · Received April 20, 2012

    Report

    Report Number
    1822565-2012-00877
    Event Type
    Injury
    Date Received
    April 20, 2012
    Date of Event
    December 12, 2011
    Report Date
    February 25, 2020
    Manufacturer
    ZIMMER INC
    Product Code
    NJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NEITHER SURGICAL NOTES NOR X-RAYS WERE PROVIDED, THEREFORE FIT AND ORIENTATION COULD NOT BE EVALUATED. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL OR TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNK. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO 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 INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL EXAMINATION OF THE RETURNED COMPONENTS (TIBIAL IMPLANT, ARTICULAR SURFACE, TAPER PLUG) NOTED THAT THEY EXHIBIT SIGNS OF BEING IMPLANTED. THE BACKSIDE OF THE TIBIAL IMPLANT IS COMPLETELY FREE OF BONE CEMENT REMAIN AND IS SCRATCHED AND STAINED. ONE OF THE FOUR HOLE PLUGS IS MISSING AND THE TAPER PLUG IS STILL AFFIXED TO THE KEEL OF THE TIBIAL IMPLANT. THE SUPERIOR SURFACE OF THE TIBIAL IMPLANT IS ALSO STAINED AND SCRATCHED. THE CONDYLAR SURFACES OF THE ARTICULAR SURFACE ARE SLIGHTLY WORN WHILE THE INFERIOR SURFACE IS PITTED AND HAS WEAR LINES. DIMENSIONAL ANALYSIS OF THE PRODUCTS IDENTIFIERS PASSED. THE FEMORAL COMPONENT WAS NOT RETURNED. LOOSENING OF THE TIBIAL IMPLANT IS CONFIRMED. THE DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. PER THE INSTRUCTIONS FOR USE OF THE IMPLANTS, LOOSENING OF THE PROSTHETIC KNEE COMPONENTS IS A KNOWN POTENTIAL ADVERSE EFFECTS ASSOCIATED WITH THE TKA PROCEDURE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S KNEE WAS REVISED DUE TO LOOSENING. INITIAL REVISION WAS SCHEDULED FOR (B)(6) 2011, BUT WAS NOT PERFORMED DUE TO COMPLICATIONS INTUBATING THE PT.

    Description of Event or Problem · 1

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS-FLEX FEMORAL COMPONENT NJL ZIMMER INC 60739906

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention NEXGEN STEMMED TIBIAL COMPONENT:| MANUFACTURED AT ZIMMER (B)(4)| CATALOG #00598004701, LOT #60795945,