BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM

    MDR report key: 16683587 · Received April 4, 2023

    Report

    Report Number
    MW5116324
    Event Type
    Injury
    Date Received
    April 4, 2023
    Date of Event
    March 19, 2023
    Report Date
    March 30, 2023
    Manufacturer
    ZIMMER, INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IMPLANTED TITANIUM PLATE FROM ZIMMER (K100111) MODEL NUMBER 0203263109 FAILED AND SNAPPED IN HALF. THIS CAUSED SEVERE PAIN AND INABILITY TO WALK. THIS PLATE HAD BEEN SURGICALLY IMPLANTED ON (B)(6) 2021 AT LOVELACE MEDICAL CENTER, ALBUQUERQUE NM. THIS PLATE HAD BEEN IMAGED ON (B)(6) 2023 AND DID NOT SHOW FAILURE. THE RESULTING FAILURE ON (B)(6) 2023 REQUIRED EMERGENCY ADMISSION AND CORRECTIVE SURGERY ON (B)(6) 2023 AT (B)(6). THE PLATE AND SCREWS WERE REMOVED, AND SUBSEQUENTLY REPLACED WITH A SIMILAR PLATE AND INCLUSIVE OF BONE GRAFT FROM HIP AREA WITH STRYKER BONE MATRIX PUTTY BIOLOGICS. HAVE REQUESTED PROVIDER TO HOLD BROKEN IMPLANT FOR INSPECTION AND EVALUATION. IMPRESSION FINDINGS/IMPRESSION: LEFT HIP ARTHROPLASTY AND LATERAL PLATE FIXATION HARDWARE NOTED. NEW HARDWARE FRACTURE OF LATERAL PLATE JUST ABOVE THE DISTAL ASPECT OF THE ARTHROPLASTY FEMORAL STEM, WITH SOME MILD MEDIAL ANGULATION OF THE MORE DISTAL FEMUR. ELECTRONIC SIGNATURE SIGNED BY: ROBERT BLAKELY; NARRATIVE AP PELVIS, WITH DEDICATED AP AND CROSSTABLE LATERAL VIEWS OF THE LEFT PROXIMAL FEMUR CLINICAL HISTORY: LEFT HIP PAIN, COMPARISONS: (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549011 NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM PLATE, FIXATION, BONE HRS ZIMMER, INC. 0203263109 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Hospitalization| O| S| R AMLODIPINE 5 MG| B12| CHOLECALCIFEROL 50 MCG| CREON 76,000 DELAYED RELEASE| DULOXETINE 30 MG| HUMIRA 40 MG| MULTI-VITAMIN| TERIPARATIDE 20MCG/DOSE