BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LEGACY CONSTRAINED CONDYLAR KNEE ARTICULAR SURFACE

    MDR report key: 5811662 · Received July 21, 2016

    Report

    Report Number
    0001822565-2016-02517
    Event Type
    Injury
    Date Received
    July 21, 2016
    Date of Event
    June 23, 2016
    Report Date
    July 12, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK960279
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: MEDICAL PRODUCT ¿ NEXGEN LCCK OPTION FEMORAL, SIZE E, GREEN/STR BLUE , RIGHT CATALOG# 00-5994-015-92 LOT# 61646372, NEXGEN STRAIGHT STEM EXTENSION STRAIGHT STEM 14MM X 145MM CATALOG# 00-5988-010-14 LOT# 62477213, NEXGEN OFFSET STEM EXTENSION 11MM X 145MM CATALOG# 00-5988-020-11 LOT# 62047399, NEXGEN PRECOAT STEMMED TIBIAL PLATE, SIZE 3, YELLOW/STR YELLOW CATALOG# 00-5980-037-01 LOT# 62503795N, NEXGEN 15MM TIBIAL AUGMENT BLOCK, SIZE 3 CATALOG# 00-5988-003-38 LOT# 62491246. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE COMPATIBILITY MATRIX IDENTIFIED THAT ALL THE COMPONENTS ARE COMPATIBLE (FEMORAL WITH ARTICULAR SURFACE AND PATELLA; TIBIA WITH ARTICULAR SURFACE). SURGICAL NOTES WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. WITHIN THE NEXGEN KNEE SYSTEM PACKAGING INSERT, DISLOCATION AND/OR JOINT INSTABILITY ARE ADDRESSED AS POSSIBLE ADVERSE EFFECTS, AND IS THEREFORE A KNOWN RISK OF THIS PROCEDURE. MOREOVER, IT IS MENTIONED IN PATIENT COUNSELING INFORMATION, ¿FAILURE OF TOTAL PROSTHESES ARE MORE LIKELY TO OCCUR IN HEAVY PATIENTS." ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO CORRECT INFORMATION. (B)(4). THE EVALUATION OF THE X-RAYS CONFIRMS THE COMPLAINT. X-RAY IMAGES ASSESSMENT SHOWS NEXGEN LEGACY CONSTRAINED CONDYLAR KNEE ARTHROPLASTY WITH MIGRATION/ROTATION; ELEVATED TIBIAL SPINE EXHIBITS AN ABNORMAL ORIENTATION TILTED ANTERIORLY AND IS DISASSOCIATED FROM THE FEMORAL INTERCONDYLAR BOX. 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 PATIENT WAS REVISED OF HER ARTICULAR SURFACE KNEE IMPLANT DUE TO PAIN, LOOSENING, DISLOCATION AND INABILITY TO EXTEND THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464605 NEXGEN LEGACY CONSTRAINED CONDYLAR KNEE ARTICULAR SURFACE KNEE PROSTHESIS JWH ZIMMER, INC. 60907388

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R