BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TORNIER PYROCARBON HUM HEAD DIA 48MMX18MMX4.0MM ECC

    MDR report key: 22382229 · Received July 2, 2025

    Report

    Report Number
    3000931034-2025-00354
    Event Type
    Injury
    Date Received
    July 2, 2025
    Date of Event
    June 2, 2025
    Report Date
    October 1, 2025
    Manufacturer
    TORNIER S.A.S.
    Product Code
    QKW
    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

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    CORRECTION: SECTION D: GTIN AND EXPIRATION DATE UPDATED. SECTION H: MANUFACTURING DATE UPDATED. THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCE WAS PROVIDED. A DEVICE INSPECTION WAS NOT POSSIBLE SINCE THE AFFECTED DEVICE WAS NOT RETURNED. SINCE AN X-RAY WAS PROVIDED, THE OPINION OF THE MEDICAL EXPERT WAS SOUGHT AND STATED AS FOLLOWS: THIS CASE DESCRIBES THE EXPLANTATION OF A STRYKER SHOULDER ARTHROPLASTY DEVICE BECAUSE OF THE CLINICAL SUSPICION OF AN INFECTION. THE DEVICE WAS EXPLANTED INDEED. THERE¿S HOWEVER NO PROOF OF INFECTION: THAT IS NO INFORMATION ON POSITIVE INTRAOPERATIVE MICROBIAL CULTURES IS AVAILABLE. THE IMPLANT LOOKS WELL-FIXED (CONFIRMED BY THE AVAILABLE INFORMATION) AND WELL-POSITIONED, WITHOUT SIGNS OF INFECTION ON THE IMAGES. THERE¿S HOWEVER, NO TIMESTAMP ON THE X-RAY, SO IT IS UNKNOWN WHEN IT WAS TAKEN AND STRICTLY IF IT BELONGS TO THE PATIENT. FAILURE OF TOTAL SHOULDER REPLACEMENT OVER TIME IS A KNOWN COMPLICATION. IN CASE OF A REVISION PROCEDURE A MEDICAL OPINION AIMING TO DETERMINE THE ROOT CAUSE OF THE FAILURE IS PART OF THE INTERNAL INVESTIGATION PROCESS. SUFFICIENT (RADIOLOGICAL AND CLINICAL) INFORMATION MUST BE PROVIDED TO ENABLE A MEANINGFUL CLINICAL ASSESSMENT AND TO IDENTIFY POSSIBLE CAUSES OF FAILURE. IN CASES WHERE NO SUCH INFORMATION IS AVAILABLE, THIS ASSESSMENT IS LIMITED. NO CONCLUSIVE STATEMENT CAN BE PROVIDED, BECAUSE KEY CLINICAL INFORMATION (E.G. CLINICAL STATUS, EXACT SYMPTOMS AND RANGE OF MOTION OF THE PATIENT, ASSESSMENT OF THE TREATING PHYSICIAN) IS MISSING. DUE TO THESE LIMITATIONS, I AM UNABLE TO PROVIDE STATEMENTS ABOUT THE PATIENT, THE PROCEDURE, AND/OR THE DEVICE IN RELATION TO CAUSE OF THE FAILURE. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT PRIMARY SHOULDER HEMI-ARTHROPLASTY, ON (B)(6) 2024, WITH AN ASCEND FLEX STEM & PYROCARBON HEAD IMPLANTED. LATER, THE PATIENT COMPLAINED OF PAIN, SWELLING AROUND PROSTHETIC SHOULDER JOINT, CLINICAL SIGNS, ACCORDING TO THE SURGEON, OF A SUSPECTED C. ACNES INFECTION. DURING SURGERY, REDNESS & SWELLING WAS OBVIOUS AROUND OLD SUTURE LINE. MULTIPLE SPECIMENS WERE TAKEN DURING THE WOUND EXPOSURE, AND SURGEON MADE THE DECISION TO REMOVE THE IMPLANTS, AS A 1ST STAGE OF A 2 X STAGE REVISION. PYROCARBON HEAD REMOVED, THEN HUMERAL STEM REMOVED, WITH MODERATE DIFFICULTY, AS IT WAS WELL FIXED - MINIMAL PROXIMAL BONE LOST. MORE SPECIMENS TAKEN, COPIOUS LAVAGE, AND A CEMENTED ANTIBIOTIC TEMPORARY SPACER STEM INSERTED. 2ND STAGE PROCEDURE IS TO BE BOOKED IN THE FUTURE WHEN CLINICAL MARKERS ARE WITHIN NORMAL LIMITS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT PRIMARY SHOULDER HEMI-ARTHROPLASTY, ON (B)(6) 2024, WITH A ASCEND FLEX STEM & PYROCARBON HEAD IMPLANTED. LATER, THE PATIENT COMPLAINED OF PAIN, SWELLING AROUND PROSTHETIC SHOULDER JOINT, CLINICAL SIGNS, ACCORDING TO THE SURGEON, OF A SUSPECTED C.ACNES INFECTION. DURING SURGERY, REDNESS & SWELLING WAS OBVIOUS AROUND OLD SUTURE LINE. MULTIPLE SPECIMENS WERE TAKEN DURING THE WOUND EXPOSURE, AND SURGEON MADE THE DECISION TO REMOVE THE IMPLANTS, AS A 1ST STAGE OF A 2 X STAGE REVISION. PYROCARBON HEAD REMOVED, THEN HUMERAL STEM REMOVED, WITH MODERATE DIFFICULTY, AS IT WAS WELL FIXED - MINIMAL PROXIMAL BONE LOST. MORE SPECIMENS TAKEN, COPIOUS LAVAGE, AND A CEMENTED ANTIBIOTIC TEMPORARY SPACER STEM INSERTED. 2ND STAGE PROCEDURE IS TO BE BOOKED IN THE FUTURE WHEN CLINICAL MARKERS ARE WITHIN NORMAL LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1368332 TORNIER PYROCARBON HUM HEAD DIA 48MMX18MMX4.0MM ECC SHOULDER JOINT HUMERAL CERAMIC HEAD QKW TORNIER S.A.S. 5325AZ

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Unknown Required Intervention