BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LONG OFFSET STEM EXTENSION

    MDR report key: 5657726 · Received May 16, 2016

    Report

    Report Number
    0001822565-2016-01580
    Event Type
    Injury
    Date Received
    May 16, 2016
    Date of Event
    March 2, 2016
    Report Date
    January 26, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PP060037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ZIMMER NEXGEN RHK FEMORAL COMPONENT CATALOG #: 00-5880-013-01 LOT #: 61676470, ZIMMER NEXGEN RHK TIBIAL PLATE CATALOG #: 00-5880-003-00 LOT #: 61762214, ZIMMER NEXGEN OFFSET STEM EXTENSION CATALOG #: 00-5988-020-13 LOT #: 61818191, ZIMMER NEXGEN RHK ARTICULAR SURFACE CATALOG #: 00-5880-030-12 LOT #: 61651832, ZIMMER NEXGEN TM FEMORAL CONE CATALOG #: 00-5450-012-53 LOT#: 61540795, ZIMMER NEXGEN TM TIBIAL CONE CATALOG #: 00-5450-059-05 LOT #: 61626525. THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. NO DEVICES WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. PHOTOGRAPHS OF THE EXPLANTED DEVICES SHOW THAT THE STEM EXTENSION HAD FRACTURED AT THE TAPER. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE STEM EXTENSION IDENTIFIED NO DEVIATIONS OR ANOMALIES. THIS DEVICE IS USED FOR TREATMENT. A COMPLAINT HISTORY SEARCH IDENTIFIED NO OTHER COMPLAINTS FOR LOT 61589318. OPERATIVE NOTES FROM THE SURGERY WHERE THE STEM EXTENSION WAS IMPLANTED WERE NOT RETURNED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. REVIEW OF THE IMPLANTED DEVICES DID NOT IDENTIFY ANY COMPATIBILITY ISSUES. A MEDICAL REPORT FROM AN OFFICE VISIT APPROXIMATELY TWO MONTHS BEFORE THE REVISION STATES THAT THE PATIENT WAS EXPERIENCING PAIN AND INABILITY TO WALK WITH NO RECALLABLE ACCIDENT OR TRAUMA. THE REPORT STATES THAT X-RAYS SHOWED GOOD ALIGNMENT OF THE COMPONENTS BUT ALSO SHOWED IMPLANT LOOSENING. OPERATIVE NOTES FROM THE REVISION SURGERY STATE THAT THE PATIENT WAS DIAGNOSED WITH RHEUMATOID ARTHRITIS AND PREVIOUSLY UNDERWENT BILATERAL KNEE REPLACEMENT WITH REVISIONS ON EACH SIDE. THE NOTES STATE THAT THE RADIOGRAPHS REVEALED A PERI-PROSTHETIC FRACTURE AS WELL AS FRACTURE OF THE PROSTHESIS AT THE JUNCTION OF THE DISTAL FEMUR WITH THE STEM. DURING THE REVISION IT WAS NOTED THAT THERE WAS A FRACTURE AT THE JUNCTION OF THE FEMORAL COMPONENT AND THE STEM AND ALSO A FRACTURE OF THE DISTAL FEMUR. IT WAS NOTED THAT THE WHOLE FEMORAL CONDYLE HAD FLEXED AND DISASSOCIATED FROM THE DISTAL FEMUR. THE BONE AT THE DISTAL FEMUR WAS ATROPHIC WITH NO FEMORAL CONDYLES. THE TIBIAL COMPONENTS WERE NOTED TO BE WELL FIXED AND WERE NOT REVISED. PER THE NEXGEN ROTATING HINGE KNEE PACKAGE INSERT, LOOSENING OR FRACTURE/DAMAGE OF THE PROSTHETIC KNEE COMPONENTS OR SURROUNDING TISSUES IS A KNOWN RISK OF THIS PROCEDURE. THE PACKAGE INSERT ALSO STATES THAT BECAUSE THE ROTATING HINGE KNEE IS A HIGHLY CONSTRAINED DEVICE, THE RISK OF COMPONENT BREAKAGE, LOOSENING, AND POLYETHYLENE WEAR MAY BE GREATER THAN FOR LESS CONSTRAINED KNEE IMPLANTS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO SEVERE PAIN, CRACKING NOISE, INABILITY TO BEAR WEIGHT, AND SWELLING. DURING THE REVISION IT WAS DISCOVERED THAT THE FEMORAL STEM WAS BROKEN AT ITS JUNCTION WITH THE FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311985 NEXGEN LONG OFFSET STEM EXTENSION KNEE PROSTHESIS JWH ZIMMER, INC. N/A 61589318

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R