BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTICULAR SURFACE FIXED BEARING CONSTRAINED CONDYLAR KNEE (CCK)

    MDR report key: 25184083 · Received May 15, 2026

    Report

    Report Number
    0001822565-2026-01598
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    April 23, 2026
    Report Date
    May 15, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00889024554313
    PMA / PMN Number
    K191625
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D1: BRAND NAME : ARTICULAR SURFACE FIXED BEARING CONSTRAINED CONDYLAR KNEE (CCK) LEFT 10 MM HEIGHT USE WITH TIBIA SIZES E, F / REVISION FEMUR SIZES 7, 7+, 9, 9+ WITH L THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT HAIR WAS OBSERVED IN THE PACKAGE OF A PRK CCK BEARING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235648 ARTICULAR SURFACE FIXED BEARING CONSTRAINED CONDYLAR KNEE (CCK) PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. 67110551 00889024554313

    Patients

    Seq Age Sex Outcome Treatment
    1