BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX GSF FEMORAL COMPONENT

    MDR report key: 2704555 · Received August 15, 2012

    Report

    Report Number
    1822565-2012-01731
    Event Type
    Injury
    Date Received
    August 15, 2012
    Date of Event
    September 23, 2011
    Report Date
    March 2, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: CATALOG #00596204010, NEXGEN PROLONG LPS-FLEX ARTICULAR SURFACE, LOT #61154866 CATALOG #00111214001, PALACOS RADIOPAQUE BONE CEMENT, LOT #67654195 - THIS BONE CEMENT IS MANUFACTURED AT HERAEUS MEDICAL AND DISTRIBUTED THROUGH ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS. EVALUATION SUMMARY: SURGICAL NOTES WERE RETURNED FOR BOTH THE IMPLANT AND REVISION SURGERIES. THE IMPLANT SURGICAL NOTES INDICATED THAT THE TRIAL REDUCTION ALLOWED THE KNEE TO COME TO FULL FLEXION AND FULL EXTENSION WITH NO VARUS OR VALGUS INSTABILITY. THE REVISION SURGICAL NOTES STATE THAT X-RAYS SHOWED GOOD ALIGNMENT AND NO EVIDENCE OF LOOSENING HOWEVER, PHYSICAL EXAM SHOWED INSTABILITY AT FULL EXTENSION. INTRA-OPERATIVELY THE ARTICULAR SURFACE WAS REVISED TO A 12MM TO OBTAIN STABILITY AND THE FEMORAL COMPONENT WAS FOUND TO BE LOOSE AND WAS EASILY REMOVED WITH AN OSTEOTOME. X-RAYS WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION. 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. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. FEMORAL COMPONENT AND ARTICULAR SURFACE WERE RETURNED. VISUAL INSPECTION OF BOTH COMPONENTS IDENTIFIED SIGNS OF USE. BONE CEMENT WAS ADHERED TO THE FEMORAL COMPONENT. ADDITIONAL INFORMATION DOES NOT AFFECT THE ROOT CAUSE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT'S RIGHT KNEE WAS REVISED DUE TO PAIN, INSTABILITY, AND LOOSENING OF THE FEMORAL COMPONENT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN, INSTABILITY, AND LOOSENING OF THE FEMORAL COMPONENT TWO (2) YEARS, SEVEN (7) MONTHS POST PRIMARY IMPLANTATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS-FLEX GSF FEMORAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 61123580

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R LOT#67654195 - THIS BONE CEMENT IS MFG AT HERAEUS| SURGICAL PRODUCTS.| MEDICAL AND DISTRIBUTED THROUGH ZIMMER ORTHOPAEDIC| PALACOS RADIOPAQUE BONE CEMENT: CAT#00111214001,