BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX GSF FEMORAL COMPONENT

    MDR report key: 1913930 · Received November 30, 2010

    Report

    Report Number
    1822565-2010-01205
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    November 22, 2010
    Report Date
    February 27, 2020
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS REC'D FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. WITH THE INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. EVALUATION CODES: NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. 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 AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE REC'D, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    MANUFACTURING DOCUMENTATION FOR THE FEMORAL COMPONENT WAS REVIEWED AND INDICATES THAT THIS DEVICE WAS MANUFACTURED, INSPECTED, AND PACKAGED TO SPECIFICATION. THE NEW INFORMATION PROVIDED GIVES NO INDICATIONS OF A ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    OTHER DEVICES USED: THESE DEVICES EXPLANTED ON (B)(6) 2010. CATALOG #00111314001, PALACOS R+G BONE CEMENT, LOT #60769610; THIS BONE CEMENT IS MANUFACTURED AT HERAEUS MEDICAL AND DISTRIBUTED THROUGH ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS. CATALOG #0059860470, NEXGEN STEMMED TIBIAL COMPONENT, LOT #60853748; MANUFACTURED AT ZIMMER B.V., (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    IT IS NOW KNOWN THAT THE PATIENT WAS REVISED DUE TO TIBIAL LOOSENING, AND ONLY THE TIBIAL SIDE COMPONENTS WERE REMOVED DURING THIS PROCEDURE. THE PRIMARY NOTES STATE THE FINAL COMPONENTS WERE CEMENTED INTO PLACE "WITH THE EXCEPTION OF NO CEMENTATION OF THE STEM OF THE TIBIAL TRAY." THE SURGICAL TECHNIQUE ASSEMBLY INSTRUCTIONS INCLUDE THE FOLLOWING STATEMENT: "IF BONE CEMENT IS BEING USED, APPLY CEMENT TO THE UNDERSIDE OF THE TIBIAL PLATE, AROUND THE KEEL, ON THE RESECTED TIBIAL SURFACE, AND IN THE TIBIAL IM CANAL." THE REVISION NOTES STATE THERE WAS A HUGE AMOUNT OF SYNOVITIS AND SYNOVECTOMY WAS PERFORMED. THE TIBIAL COMPONENT AND THE CEMENT AROUND IT WERE REMOVED "PIECE MEAL". NO OTHER DESCRIPTION OR CONDITION OF THE COMPONENT WAS PROVIDED. ROOT CAUSE FOR THIS EVENT APPEARS RELATED TO THE SURGICAL TECHNIQUE USED; HOWEVER, THIS CANNOT BE STATED DEFINITIVELY.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UDI # (B)(4). VISUAL EXAMINATION OF THE RETURNED COMPONENTS (TIBIAL IMPLANT, ARTICULAR SURFACE) NOTED THAT THEY EXHIBIT SIGNS OF BEING IMPLANTED. THE ARTICULAR SURFACE IS STILL AFFIXED TO THE TOP OF THE TIBIAL COMPONENT AND ITS CONDYLAR SURFACES ARE SCRATCHED AND PITTED. THE BACKSIDE AND KEEL OF THE TIBIAL COMPONENT ARE COMPLETELY FREE OF BONE CEMENT REMAINS. THE CEMENT-FREE BACKSIDE IS SCRATCHED. DIMENSIONAL ANALYSIS OF THE PRODUCT IDENTIFIERS PASSED. THIS NEW INFORMATION DOES NOT AFFECT THE PREVIOUSLY COMPLETED INVESTIGATION. 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 IS REPORTED THAT THE PT WAS REVISED DUE TO PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. FOLLOWING THE PATIENT EXPERIENCED INTENSE PAIN AND A FALL. SUBSEQUENTLY, PATIENT WAS REVISED APPROXIMATELY TWO (2) YEARS, FIVE (5) MONTHS, DUE TO TIBIAL COMPONENT LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS-FLEX GSF FEMORAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER, INC. 00576401452 60847725

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention