BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - BIOMATERIAL - CEMENT: TRAUMACEM

    MDR report key: 24968574 · Received April 23, 2026

    Report

    Report Number
    8030965-2026-03742
    Event Type
    Injury
    Date Received
    April 23, 2026
    Date of Event
    February 6, 2026
    Manufacturer
    SYNTHES GMBH
    Product Code
    NDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KASHA S, YALAMANCHILI RK, GURRAM A, YAMAJALA S, ROHIT GPRK. OSTEONECROSIS OF FEMORAL HEAD AFTER CEMENT AUGMENTED TFNA NAILING FOR AN INTERTROCHANTERIC FRACTURE: A CASE REPORT. TRAUMA CASE REP. 2026 FEB 6;61:101305. DOI: 10.1016/J.TCR.2026.101305. PMID: 41717327; PMCID: PMC12914288. OBJECTIVE/METHODS/STUDY DATA: THE PURPOSE OF THIS CASE REPORT IS TO DESCRIBE AND HIGHLIGHT THE OCCURRENCE OF OSTEONECROSIS OF THE FEMORAL HEAD (ONFH) FOLLOWING CEMENT-AUGMENTED TFNA (TROCHANTERIC FEMORAL NAIL¿ADVANCED) FIXATION FOR AN INTERTROCHANTERIC FEMORAL FRACTURE, DESPITE APPROPRIATE FRACTURE REDUCTION AND FIXATION. AN 85-YEAR-OLD FEMALE WITH MULTIPLE COMORBIDITIES (HYPERTENSION, TYPE II DIABETES, PRIOR CEREBROVASCULAR ACCIDENT) SUSTAINED A REVERSE OBLIQUE INTERTROCHANTERIC FRACTURE CLASSIFIED AS AO/OTA 31A3.3. SHE WAS MANAGED WITH CLOSED REDUCTION AND INTERNAL FIXATION USING TFNA (DEPUY SYNTHES, RAYNHAM, MASSACHUSETTS, USA). CLOSED REDUCTION COUPLED WITH INDIRECT REDUCTION TECHNIQUES USING HOFFMAN RETRACTOR TO REDUCE ANTERIOR SPIKE WAS USED INTRAOPERATIVELY. FOLLOWING SATISFACTORY REDUCTION, TFNA WAS INTRODUCED AND AUGMENTED WITH A 3 ML OF TRAUMACEM¿ V (POLY METHYL METHA ACRYLATE - DEPUY SYNTHES, RAYNHAM, MASSACHUSETTS, USA), THAT WAS INJECTED IN INCREMENTAL DOSAGES OF 2 ML AND 1 ML THROUGH THE HELICAL BLADE. FOLLOW-UP PERIOD REPORTED IN THE STUDY WAS 23 MONTHS POST-FIXATION. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: TFNA (TROCHANTERIC FEMORAL NAIL - ADVANCED¿; DEPUY SYNTHES) NAIL, AUGMENTED WITH A 3 ML OF TRAUMACEM¿ V (POLY METHYL METHA ACRYLATE - DEPUY SYNTHES, RAYNHAM, MASSACHUSETTS, USA) AND HELICAL BLADE ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: TFNA (QTY 1): (N=1): 85 YEAR OLD FEMALE PATIENT, AT 18 MONTHS OF FOLLOW UP, RADIOGRAPH SHOWED OSTEONECROSIS OF FEMORAL HEAD (ONF) AND THE PATIENT WAS EVALUATED WITH A CT (COMPUTERISED TOMOGRAPHY) SCAN OF HIP, WHICH REVEALED CRESCENT SIGN. SHE WAS ADVISED REGULAR EVALUATION TO LOOK FOR PROGRESSION OF ONFH. AT 23RD MONTH OF POST-OPERATIVE FOLLOW UP; SHE PRESENTED WITH COMPLAINTS OF PAINFUL HIP AND DISABILITY LASTING FROM 6 WEEKS AND UPON EVALUATION IT WAS NOTED THAT ONFH PROGRESSED WITH CUT THROUGH OF HELICAL BLADE CAUSING A SIGNIFICANT DEFECT IN ACETABULUM. SHE UNDERWENT IMPLANT REMOVAL AND A TOTAL HIP ARTHROPLASTY (THA) AND INTRAOPERATIVELY IT WAS NOTED THAT THERE WAS A SIGNIFICANT ACETABULAR DEFECT THAT NEEDED AUGMENTS AND THE FEMORAL HEAD WAS NECROTIC WITH COMPLETE DELAMINATION OF ARTICULAR CARTILAGE. POST THA, PATIENT IS INDEPENDENTLY AMBULATING WITHOUT ANY FUNCTIONAL LIMITATION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - TRAUMACEM (QTY 1): (N=1): 85 YEAR OLD FEMALE PATIENT, AT 18 MONTHS OF FOLLOW UP, RADIOGRAPH SHOWED OSTEONECROSIS OF FEMORAL HEAD (ONF) AND THE PATIENT WAS EVALUATED WITH A CT (COMPUTERISED TOMOGRAPHY) SCAN OF HIP, WHICH REVEALED CRESCENT SIGN. SHE WAS ADVISED REGULAR EVALUATION TO LOOK FOR PROGRESSION OF ONFH. AT 23RD MONTH OF POST-OPERATIVE FOLLOW UP; SHE PRESENTED WITH COMPLAINTS OF PAINFUL HIP AND DISABILITY LASTING FROM 6 WEEKS AND UPON EVALUATION IT WAS NOTED THAT ONFH PROGRESSED WITH CUT THROUGH OF HELICAL BLADE CAUSING A SIGNIFICANT DEFECT IN ACETABULUM. SHE UNDERWENT IMPLANT REMOVAL AND A TOTAL HIP ARTHROPLASTY (THA) AND INTRAOPERATIVELY IT WAS NOTED THAT THERE WAS A SIGNIFICANT ACETABULAR DEFECT THAT NEEDED AUGMENTS AND THE FEMORAL HEAD WAS NECROTIC WITH COMPLETE DELAMINATION OF ARTICULAR CARTILAGE. POST THA, PATIENT IS INDEPENDENTLY AMBULATING WITHOUT ANY FUNCTIONAL LIMITATION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - NAIL HEAD ELEM: TFNA HELICAL BLADE (QTY 1): (N=1): ONFH PROGRESSED WITH CUT THROUGH OF HELICAL BLADE CAUSING A SIGNIFICANT DEFECT IN ACETABULUM. SHE UNDERWENT IMPLANT REMOVAL AND A TOTAL HIP ARTHROPLASTY (THA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619522 UNK - BIOMATERIAL - CEMENT: TRAUMACEM POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT NDN SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1