BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX FEMORAL COMPONENT

    MDR report key: 2764281 · Received September 26, 2012

    Report

    Report Number
    1822565-2012-01977
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    June 11, 2012
    Report Date
    February 25, 2020
    Manufacturer
    ZIMMER, INC.
    Product Code
    NJL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. NEITHER SURGICAL NOTES NOR X-RAYS WERE PROVIDED, THEREFORE FIT AND ORIENTATION COULD NOT BE EVALUATED. PATIENT 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 UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    OTHER DEVICES USED: CATALOG #00111214001, PALACOS R BONE CEMENT, LOT #68994215. CATALOG #00111214001, PALACOS R BONE CEMENT, LOT #69264223. THIS BONE CEMENT IS MANUFACTURED BY HERAEUS MEDICAL AND DISTRIBUTED BY ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS. REVIEW OF SURGICAL REPORTS PROVIDED DID NOT REVEAL INDICATIONS THAT THE RECOMMENDED SURGICAL TECHNIQUE WAS NO: FOLLOWED. THE REVISION SURGICAL REPORT STATES THAT THE FEMORAL COMPONENT WAS REMOVED QUITE EASILY, AND THAT THERE WAS NO GOOD CEMENT PENETRATION INTO THE FEMORAL BONE. THIS MAY INDICATE THAT THE BONE CEMENT WAS PARTIALLY CURED BY THE TIME THE COMPONENT WAS APPLIED, HOWEVER, A DEFINITIVE ROOT CAUSE STILL CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCTS IDENTIFIED SURFACE SCRATCHES ON THE FEMORAL COMPONENT. BONE CEMENT WAS PRESENT ON THE BACKSIDE OF THE FEMORAL COMPONENT. DIMENSIONAL ANALYSIS OF THE PRODUCT DETERMINED THAT THE PRODUCT, WHERE MEASURED, WAS CONFORMING TO PRINT SPECIFICATIONS. THE UPDATED INFORMATION DOES NOT CHANGE THE PREVIOUS INVESTIGATION CONCLUSIONS. PER THE NEXGEN CR-FLEX AND LPS-FLEX PACKAGE INSERT, PAIN AND LOOSENING ARE KNOWN POTENTIAL ADVERSE EFFECTS OF THIS 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 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 PAIN.

    Description of Event or Problem · 1

    ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS-FLEX FEMORAL COMPONENT PROSTHESIS KNEE NJL ZIMMER, INC. 61390321

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention NEXGEN STEMMED TIBIAL COMPONENT:| CATALOG #00596204210, LOT #61410097| CATALOG #00598004702, LOT #61379859| NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE:| MANUFACTURED AT ZIMMER (B)(4)