BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR HEAD 28/+4 'L' 12/14

    MDR report key: 24176495 · Received January 26, 2026

    Report

    Report Number
    0009613350-2026-00026
    Event Type
    Injury
    Date Received
    January 26, 2026
    Date of Event
    December 30, 2025
    Report Date
    April 30, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    MEH
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4: THIS DEVICE IS SOLD OUTSIDE THE U.S AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). D10: CONCOMITANT MEDICAL PRODUCTS: DESC: DURAL ALPHA INSERT NEUTR KK/28; ITEM: 01.00013.211; LOT: 2217383. G2: FOREIGN - EVENT OCCURRED IN AUSTRALIA. G4: PREMARKET IDENTIFICATION: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K200959. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, SIXTEEN YEARS LATER, UNDERWENT A REVISION DUE TO RECURRENT ANTERIOR DISLOCATIONS. PRIOR TO THE PROCEDURE, IT WAS NOTED THE CUP WAS CLOSED AND OVER ANTEVERTED, SPINE STIFFNESS, AND POSSIBLE IMPINGEMENT. THE HEAD AND LINER WERE REPORTED AS REVISED DUE TO INSTABILITY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609189 COCR HEAD 28/+4 'L' 12/14 PROSTHESIS, HIP MEH ZIMMER GMBH 2230073

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H11 NARRATIVE