BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL COMPONENT OPTION FOR CEMENTED USE SIZE E LEFT

    MDR report key: 12313989 · Received August 12, 2021

    Report

    Report Number
    3007963827-2021-00173
    Event Type
    Injury
    Date Received
    August 12, 2021
    Date of Event
    July 7, 2021
    Report Date
    September 3, 2021
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    JWH
    PMA / PMN Number
    K060370
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: REF 00-5980-090-00, LOT: 62493855 STEM EXTENSION SCREW. REF 00-5980-037-02, LOT: 62531239 TIBIA. REF 00-5764-015-51, LOT: 62539937 FEMORAL. REF 00-5960-099-00, LOT: 62484992 TAPER PLUG. REF 00-5972-065-32, LOT: 62467065 PATELLA. REF 00-5962-32-12, LOT: 62517090 ARTICULAR SURFACE. REF 00-1112-140-01, LOT: 76364338 PALACOS CEMENT X3. REF 00-5791-041-00, LOT: 62524962 & 62512125 SCREWS. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: NUMBNESS, SWELLING, PAIN WITH ACTIVITIES, RADIATING PAIN, NIGHT PAIN AND INSTABILITY ON (B)(6), USES CANE, ROM: 0-100°, 'INCREASED SUBSIDENCE NOTICED IN XRAYS, WITH VALGUS ALIGNMENT LEFT TKA FEMORAL COMPONENT BONE SCAN. INCREASED ACTIVITY IN FEMUR AND TIBIA'. SPINAL + MAC, EBL<50 ML, SIGNIFICANT AMOUNT OF SYNOVITIS FROM GROSS LOOSENING OF THE FEMORAL COMPONENT, TIBIAL COMPONENT INTACT, FEMORAL BONE LOSS, 'WHEN I HAD PLACED THE TRIAL METAPHYSEAL CONE AND TRIED TO PLACE THE TRIAL FEMORAL COMPONENT IN PLACE THIS CAUSED AN ANTERIOR CORTICAL FRACTURE LINE WHICH I VISUALIZED TO ITS MOST PROXIMAL EXTENT, PROXIMALLY 5 CM.' FEMORAL COMPONENT FOUND WITH LITTLE CEMENT ATTACHED TO IT AND WAS LOOSE, 'FEMORAL COMPONENT HAD DE-BONDED FROM CEMENT'. THE COMPLAINT IS CONFIRMED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE WAS DISCARDED BY THE FACILITY. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT LEFT TKA. PATIENT WAS REVISED DUE TO AN ASEPTICALLY LOOSE FEMORAL COMPONENT APPROXIMATELY 7 YEARS, SIX MONTHS POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209695 FEMORAL COMPONENT OPTION FOR CEMENTED USE SIZE E LEFT PROSTHESIS, KNEE JWH ZIMMER ORTHOPAEDIC MFG. LTD. N/A 62539937

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE.