BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TORNIER PYROCARBON HUM HEAD DIA 43MMX16MMX1.5MM ECC

    MDR report key: 19105750 · Received April 15, 2024

    Report

    Report Number
    3000931034-2024-00206
    Event Type
    Injury
    Date Received
    April 15, 2024
    Date of Event
    March 19, 2024
    Report Date
    July 1, 2024
    Manufacturer
    TORNIER S.A.S.
    Product Code
    QKW
    UDI-DI
    03700434019469
    PMA / PMN Number
    DEN220012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED, BASED ON THE EVALUATION DONE BY MEDICAL EXPERTS ON PROVIDED X-RAY IMAGE. THE DEVICE INSPECTION WAS NOT POSSIBLE AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION AND PROVIDED IMAGE IS NOT SUFFICIENT. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, DESIGN & MANUFACTURING RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. MICROBIOLOGIST REVIEWED THE STERILIZATION PROCEDURES, ENVIRONMENTAL MONITORING, BIOBURDEN DATA AND THE DHR AND NOTED: THE SUBJECT DEVICE WAS PACKAGED ACCORDING TO ESTABLISHED DESIGN AND PROCESS SPECIFICATIONS AND WAS STERILIZED ACCORDING TO PROCEDURE. NO DEVIATION FOR A NON-CONFORMANCE COULD BE FOUND. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. HOWEVER, ON THE AVAILABLE X-RAYS MEDICAL OPINION WAS SOUGHT FROM AN EXPERIENCED INDEPENDENT MEDICAL EXPERT AS BELOW, ¿THE IMAGE SHOWS A WELL-FIXED IMPLANT, CONFIRMED BY THE SURGEON¿S OBSERVATION. THE IMAGE CONFIRMS THE INDICATION OF A PROXIMAL HUMERAL FRACTURE. THE IMAGE SHOWS NO SIGNS OF INFECTION.¿ HENCE, THE REPORTED ISSUE IS NOT CONFIRMED. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE EXACT ROOT CAUSE OF THE COMPLAINT EVENT. HOWEVER, INFECTIONS ARE OFTEN CAUSED BY A MULTITUDE OF FACTORS SUCH AS COMORBIDITY OF THE PATIENT, THE TRAUMA, THE SURGICAL INTERVENTION, AND THE AFTERCARE. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE REASSESSED.

    Description of Event or Problem · 0

    AS REPORTED: "PATIENT UNDERWENT SHOULDER HEMI-ARTHROPLASTY ON (B)(6) 2023, FOR FRACTURE PROXIMAL RIGHT HUMERUS. PATIENT HAS EXPERIENCED PAIN AND REDUCED RANGE OF MOTION OVER RECENT MONTHS. SURGEON SUSPECTS JOINT IS INFECTED, DUE TO 1 X SWAB RETURNING POSITIVE FOR BACTERIA C.ACNES. SURGEON HAS DECIDED ON A 2-STAGE REVISION ARTHROPLASTY. HUMERAL PROSTHESIS REMOVED, WITH SIGNIFICANT DIFFICULTY (HUMERAL STEM WELL FIXED). MULTIPLE TISSUE SPECIMENS TAKEN. EXPLANTED PROSTHESIS DISCARDED. CEMENT ANTIBIOTIC SPACER IMPLANTED."

    Description of Event or Problem · 0

    AS REPORTED: "PATIENT UNDERWENT SHOULDER HEMI-ARTHROPLASTY ON (B)(6) 2023, FOR FRACTURE PROXIMAL RIGHT HUMERUS. PATIENT HAS EXPERIENCED PAIN AND REDUCED RANGE OF MOTION OVER RECENT MONTHS. SURGEON SUSPECTS JOINT IS INFECTED, DUE TO 1 X SWAB RETURNING POSITIVE FOR BACTERIA C. ACNES. SURGEON HAS DECIDED ON A 2-STAGE REVISION ARTHROPLASTY. HUMERAL PROSTHESIS REMOVED, WITH SIGNIFICANT DIFFICULTY (HUMERAL STEM WELL FIXED). MULTIPLE TISSUE SPECIMENS TAKEN. EXPLANTED PROSTHESIS DISCARDED. CEMENT ANTIBIOTIC SPACER IMPLANTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808417 TORNIER PYROCARBON HUM HEAD DIA 43MMX16MMX1.5MM ECC SHOULDER JOINT HUMERAL CERAMIC HEAD/METALLIC STEM CEMENTED OR UNCEMENTED QKW TORNIER S.A.S. 2963AY 03700434019469

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Required Intervention