BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAL ALPHA INSERT NEUTR KK/28

    MDR report key: 23942169 · Received January 2, 2026

    Report

    Report Number
    0009613350-2026-00002
    Event Type
    Injury
    Date Received
    January 2, 2026
    Date of Event
    December 30, 2025
    Report Date
    April 30, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    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 US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). 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 K121874. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, G3, G6, H2, H3, H4, H6, H10, H11. NO PRODUCTS WERE RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORIES FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THESE ITEMS AND THE REPORTED PART AND LOT COMBINATIONS. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. THE REVIEW IDENTIFIED POSTOPERATIVE CHANGES OF TOTAL HIP ARTHROPLASTY WITH NONCEMENTED COMPONENTS. NO ACUTE HARDWARE COMPLICATION IS IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. D10: CONCOMITANT MEDICAL PRODUCTS: DESC: COCR HEAD 28/+4 'L' 12/14; ITEM: 14.28.07-20; LOT: 2230073. 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 THE PATIENT UNDERWENT A REVISION OF THE LINER DUE TO INSTABILITY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    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
    255229 DURAL ALPHA INSERT NEUTR KK/28 PROSTHESIS, HIP LZO ZIMMER GMBH 2217383

    Patients

    Seq Age Sex Outcome Treatment
    1