BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIP SZ. 30 PROXIMAL

    MDR report key: 23716653 · Received December 4, 2025

    Report

    Report Number
    3002788818-2025-00129
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    November 6, 2025
    Report Date
    December 4, 2025
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    OMX
    UDI-DI
    00885556858448
    PMA / PMN Number
    H010005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PRODUCT PROBLEM ASSOCIATED WITH A SMITH+NEPHEW DEVICE. THE REPORTED PROBLEM RELATES TO KNOWN RISKS WITH THE DEVICE ITSELF OR WITH ITS USE THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INVESTIGATIVE FINDINGS OR INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A PIP JOINT ARTHROPLASTY SURGERY, SURGEON IMPLANTED THE PIP SZ. 30 PROXIMAL. UPON X-RAYING, THERE WAS A NOTABLE LINE THROUGH THE IMPLANT. THE IMPLANT WAS REMOVED, AND IT CAME OUT IN TWO PIECES. ALL PIECES WERE REMOVED AND ACCOUNTED. THE FIRST PIECE WAS REMOVED BY HAND AND THE REMAINING PIECE WITH A BUR (DISINTEGRATED THE IMPLANT AND X-RAYED TO CONFIRM ALL WAS REMOVED) BEFORE IMPLANTING SECOND IMPLANT. A NEW IMPLANT WAS THEN OPENED AND USED INSTEAD. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED. IT IS UNKNOWN IF A DELAY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2727592 PIP SZ. 30 PROXIMAL HIGH DEMAND, REVISION, SEMI-CONSTRAINED, PYROLYTIC CARBON, UNCEMENTED FINGER PRO OMX ASCENSION ORTHOPEDICS, INC. 700004854 00885556858448

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown