BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAL ALPHA INSERT NEUTR JJ/36

    MDR report key: 24375175 · Received February 18, 2026

    Report

    Report Number
    0009613350-2026-00077
    Event Type
    Malfunction
    Date Received
    February 18, 2026
    Date of Event
    February 10, 2026
    Report Date
    February 18, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). IT IS UNKNOWN WHICH LOT NUMBER OF THE TWO LINERS WAS IMPACTED. THE HOSPITAL IS UNABLE TO DETERMINE WHICH OF THE TWO FOLLOWING UNUSED INSERTS IS AFFECTED: DESC: DURAL ALPHA INSERT NEUTR JJ/36 ITEM: 01.00013.710 LOT: 3262183 UDI: (B)(4) MANUFACTURING DATE: OCT 27, 2025 STERILE EXPIRATION DATE: OCT 27, 2030. DESC: DURAL ALPHA INSERT NEUTR JJ/36 ITEM: 01.00013.710 LOT: 3256832 UDI: (B)(4) MANUFACTURING DATE: OCT 29, 2025 STERILE EXPIRATION DATE: OCT 29, 2030. 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 K121874. G2: FOREIGN - EVENT OCCURRED IN GERMANY. THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CRACK WAS OBSERVED IN ONE INSERT PRIOR TO IMPLANTATION. TWO INSERTS WERE REPORTED; HOWEVER, IT IS STATED THAT ONLY ONE CONTAINS A CRACK. THE HOSPITAL IS UNABLE TO DETERMINE WHICH OF THE TWO UNUSED INSERTS IS AFFECTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435138 DURAL ALPHA INSERT NEUTR JJ/36 PROSTHESIS, HIP LZO ZIMMER GMBH 3262183

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11 NARRATIVE