BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX FEMORAL COMPONENT

    MDR report key: 2809490 · Received October 25, 2012

    Report

    Report Number
    1822565-2012-02192
    Event Type
    Injury
    Date Received
    October 25, 2012
    Date of Event
    September 24, 2014
    Report Date
    September 28, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    NJL
    Removal / Correction Number
    Z-2413-2010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE PRIMARY SURGICAL REPORT PROVIDED INDICATES THAT THE SURGICAL TECHNIQUE WAS FOLLOWED. THE NEW INFO RECEIVED GIVES NO INDICATION OF POSSIBLE CAUSE FOR FAILURE. SHOULD ADDITIONAL SUBSTANTIVE INFORM BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: CATALOG #: 00595006775, NEXGEN MIX DROP DOWN STEM EXTENSION. LOT # 60505327. CATALOG #: 00111214001, PALACOS R BONE CEMENT, LOT # 65214093, MANUFACTURED BY:(B)(4), DISTRIBUTED BY ZIMMER SURGICAL. 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 MEDICAL NOTES REVEAL THE SURGEON NOTICED UPTAKE BEHIND BOTH THE FEMORAL AND TIBIAL SIDES OF THE JOINT. THIS COULD BE INDICATIVE OF LOOSENING. ZIMMER PACKAGE INSET STATES LOOSENING OF THE PROSTHETIC KNEE COMPONENTS AS A POTENTIAL ADVERSE EFFECT OF THE SURGICAL PROCEDURE. IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THE REVISION SURGERY MAY BE RELATED TO AN ISSUE FOR WHICH ZIMMER PREVIOUSLY IMPLEMENTED A CORRECTIVE ACTION. A FIELD ACTION WAS CONDUCTED ON 04/19/2010, IN WHICH ZIMMER RECOMMENDS THE USE OF A DROP DOWN STEM EXTENSION WITH THE BASEPLATE AND CONFIRMING THE CORRECT TECHNIQUE FOR CEMENTING THE MIS TIBIAL COMPONENT WAS FOLLOWED. THE DEVICE IN QUESTION WAS IMPLANTED PRIOR TO THIS FIELD ACTION.

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: NO DEVICES NOR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNK. NEITHER SURGICAL NOTES NOR X-RAYS WERE PROVIDED; THEREFORE, FIT AND ORIENTATION COULD NOT BE EVALUATED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. 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 ADD'L 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 PT IS EXPERIENCING PAIN.

    Description of Event or Problem · 1

    IT IS FURTHER REPORTED THAT THE PT WAS REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS-FLEX FEMORAL COMPONENT NJL ZIMMER, INC. 60657211

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other| R CAT #00595004702, LOT #60677462