BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LCCK ARTICULAR SURFACE

    MDR report key: 5410028 · Received February 4, 2016

    Report

    Report Number
    1822565-2016-00195
    Event Type
    Injury
    Date Received
    February 4, 2016
    Date of Event
    February 16, 2016
    Report Date
    March 8, 2024
    Manufacturer
    .
    Product Code
    JWH
    PMA / PMN Number
    PK960279
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS PROVIDED. DEVICE WAS NOT RETURNED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. MEDICAL RECORDS REVIEW OF REVISION SURGICAL NOTES INDICATES REVISED ZIMMER LCCK IMPLANT DUE TO LOCKING BOLT HAD FAILED AND REVISED BOLT & POLY EXCHANGE. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. (B)(4). OTHER DEVICES USED: CATALOG #00599403217, NEXGEN LCCK ARTICULAR SURFACE, LOT #61602426 . THE FOLLOWING WERE MANUFACTURED BY ZIMMER (B)(4): CATALOG #00598003702, NEXGEN STEMMED PRECOAT TIBIAL COMPONENT, LOT #61639929; CATALOG #00598801215, NEXGEN STRAIGHT STEM EXTENSION, LOT #61639929. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT INFORMATION. MEDICAL PRODUCTS - NEXGEN PRECOAT STEMMED TIBIAL PLATE SIZE 4 CATALOG #: 00-5980-037-02 LOT #: 61563657, NEXGEN LCCK OPTION FEMORAL SIZE E, LEFT CATALOG #: 00-5994-015-91 LOT #: 61613136, NEXGEN STRAIGHT STEM EXTENSION 15MM X 75MM (30MM) CATALOG #: 00-5988-012-15 LOT #: 61639929, PALACOS BONE CEMENT CATALOG #: 00-1113-140-01 LOT #: 70884240, PALACOS BONE CEMENT CATALOG #: 00-1113-140-01 LOT #: 70874239, PALACOS BONE CEMENT CATALOG #: 00-1113-140-01 LOT #: 70664238. SUPPLEMENTAL INFORMATION RECEIVED IN THE FORM OF AN EMAIL WITH PICTURES OF THE RETRIEVED ARTICULAR SURFACE, STICKERS, A 2011 OPERATIVE REPORT, AND SOME PATIENT'S METRICS. PICTURES OF THE REMOVED ARTICULAR SURFACE SHOWS A LOT OF GOUGES AND SCUFFED MARKS ON THE DISTAL SURFACE IN FRONT OF THE METALLIC DOVETAIL, AS WELL AS ON THE ANTERIOR SURFACE AND ALL AROUND THE CENTRAL HOLE WHERE THE LOCKING SCREW LODGES. THE PICTURE OF THE REMOVED LOCKING SCREW SHOWS THAT THE THREADED PORTION IS MISSING. AN OPERATIVE NOTE FOR A POSTOPERATIVE HEMATOMA DRAINAGE THAT TOOK PLACE A COUPLE DAYS AFTER THE PRIMARY SURGERY STATES THAT THERE WERE NO COMPLICATIONS DURING THE PRIMARY SURGERY. A COMPLAINT HISTORY SEARCH IDENTIFIED NO OTHER COMPLAINT FOR LOT #61602426 COMBINATION OF THE ARTICULAR SURFACE. THIS SUPPLEMENTAL INFORMATION DOES NOT CHANGE THE PREVIOUS CONCLUSIONS.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING AMENDED TO REFLECT CHANGES. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO DEVIATIONS/ ANOMALIES IDENTIFIED. REVIEW OF THE COMPATIBILITY MATRIX IDENTIFIED THAT ALL THE COMPONENTS ARE COMPATIBLE. THIS DEVICE IS USED FOR TREATMENT. A COMPLAINT HISTORY SEARCH IDENTIFIED NO OTHER COMPLAINT FOR THE PART/LOT COMBINATION OF THE ARTICULAR SURFACE. SURGICAL NOTES WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENT WAS IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PER THE PACKAGE INSERT OF THE ARTICULAR SURFACE, LOOSENING OR FRACTURE/DAMAGE OF THE PROSTHETIC KNEE COMPONENTS OR SURROUNDING TISSUES IS A KNOWN ADVERSE EFFECT OF THE TKA PROCEDURE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    TO DATE, NO PRODUCT HAS BEEN RETURNED FOR EVALUATION. VISUAL AND DIMENSIONAL EVALUATIONS STILL CANNOT BE PERFORMED ON THE NEXGEN LEGACY CONSTRAINED CONDYLAR KNEE (LCCK) ARTICULAR SURFACE; THEREFORE, THE CONDITION OF THE DEVICE REMAINS UNKNOWN. THE DEVICE IS NOT ASSOCIATED WITH ANY FDA RECALL AS THE CONSUMER SUSPECTED. A DEFINITIVE ROOT CAUSE REMAINS STANDING AS CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING A FAILED IMPLANT.

    Description of Event or Problem · 1

    IT IS FURTHER REPORTED THAT THE PATIENT UNDERWENT AN ARTICULAR SURFACE EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69790 NEXGEN LCCK ARTICULAR SURFACE JWH JWH . N/A 61602426

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Hospitalization| R| O SEE H10