BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMD 25-1725 PROMADE HIP

    MDR report key: 25278963 · Received May 26, 2026

    Report

    Report Number
    3008021110-2026-00229
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    April 15, 2026
    Report Date
    May 26, 2026
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LPH
    UDI-DI
    08033390332729
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF PRODUCTION RECORDS FOR COMPLAINED COMPONENT HAS BEEN PERFORMED AND DID NOT HIGHLIGHT ANY PRE-EXISTING ANOMALY, NOR NON-CONFORMITY. FROM INFORMATION PROVIDED BY COMPLIANT SOURCE AND FOLLOW UP COMMUNICATION IT WAS LEARNED THAT SURGEON HAD ISSUES IN POSITIONING THE CUSTOM REAMER GUIDE RING THAT SHOULD HAVE ALLOWED HIM TO PROPER REAM THE BONE AND THEN IMPLANT THE CUSTOM ACETABULAR CUP. THE MANUFACTURER WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    DURING SURGERY OCCURRED ON (B)(6) 2026, AIMED TO IMPLANT HIP CUSTOM MADE DEVICE CMD 25-1725, DELAY AND CHANGE OF SURGICAL PLAN OCCURRED DUE TO FITMENT ISSUE OF THE CUSTOM INSTRUMENT. THE SURGEON COULD NOT POSITION THE CUSTOM REAMER GUIDE (REAMER STOPPER 1, INCLUDED IN INSTRUMENT SET ACETABULAR PSI 2, PN 9701.66.2AV, LOT 2606411, STERILIZATION 2600040) TO PROPER PREPARE THE BONE AND THEREFORE IMPLANT THE CUSTOM ACETABULAR CUP. DUE TO FITMENT INTRAOPERATIVE ISSUE, ABOVE MENTIONED CUSTOM DEVICE, COULD NOT BE IMPLANTED AND WAS THEREFORE USED A STANDARD DJO HIP PROSTHESIS. PATIENT DATE OF BIRTH IS (B)(6) 1971. EVENT OCCURRED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407814 CMD 25-1725 PROMADE HIP CMD 25-1725 PSI SET 2 LPH LIMACORPORATE S.P.A. 9701.66.2AV 2606411 08033390332729

    Patients

    Seq Age Sex Outcome Treatment
    1