BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN PIP IMPL

    MDR report key: 16096244 · Received January 4, 2023

    Report

    Report Number
    3002788818-2023-00001
    Event Type
    Injury
    Date Received
    January 4, 2023
    Date of Event
    July 1, 2014
    Report Date
    January 4, 2023
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    OMX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION IDENTIFIED THROUGH A REVIEW OF CLINICAL EVIDENCE FROM LITERATURE SOURCES THAT INCLUDES REFERENCE TO THE USE OF A SMITH+NEPHEW PRODUCT. THE REPORTED ISSUE(S) RELATE TO KNOWN INHERENT PROCEDURAL RISKS 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 CONFIRM A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE OR 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 CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL 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 ON LITERATURE REVIEW "TEN YEARS¿ EXPERIENCE WITH A PYROCARBON PROSTHESIS REPLACING THE PROXIMAL INTERPHALANGEAL JOINT. A PROSPECTIVE CLINICAL AND RADIOGRAPHIC FOLLOW-UP" 4 (FOUR) JOINTS IN 4 (FOUR) PATIENTS SUFFERED FROM PAIN AFTER HAVING A PIP ARTHROPLASTY USING THE ASCENSION PIP PYROCARBON IMPLANTS FOR SECONDARY OSTEOARTHRITIS AFTER FRACTURES. THE ISSUE WAS RESOLVED VIA REVISION SURGERY. THE CURRENT STATE OF HEALTH OF THE PATIENTS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1471102 UNKN PIP IMPL HIGH DEMAND, REVISION, SEMI-CONSTRAINED, PYROLYTIC CARBON, UNCEMENTED FINGER PRO OMX ASCENSION ORTHOPEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention