BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - BIOMATERIAL - CEMENT: TRAUMACEM

    MDR report key: 14831875 · Received June 27, 2022

    Report

    Report Number
    8030965-2022-04376
    Event Type
    Injury
    Date Received
    June 27, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. UNKNOWN EVENT DATE THIS REPORT IS FOR AN UNKNOWN CEMEMENT/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: SIEBENBÜRGER, G. ET AL. (2021), SCREW-TIP AUGMENTED LOCKED PLATING VERSUS PRIMARY REVERSE TOTAL SHOULDER ARTHROPLASTY IN DISPLACED PROXIMAL HUMERAL FRACTURES: A RETROSPECTIVE COMPARATIVE COHORT STUDY WITH A MEAN FOLLOW-UP OF 39 MONTHS, GERIATRIC ORTHOPAEDIC SURGERY & REHABILITATION, VOLUME 12, PAGES 1¿8 (GERMANY). THIS STUDY COMPARED THE CLINICAL AND RADIOLOGIC OUTCOMES OF SCREW-TIP AUGMENTED LOCKING PLATE OSTEOSYNTHESIS (STA) VS PRIMARY REVERSE TOTAL SHOULDER ARTHROPLASTY (RSA) IN ELDERLY PATIENTS WITH DISPLACED PROXIMAL HUMERAL FRACTURES. BETWEEN APRIL 2014 AND OCTOBER 2016, 60 PATIENTS (AGE >65 YEARS) WITH A DISPLACED PROXIMAL HUMERAL FRACTURE UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION WITH LOCKING PLATE AND FLUOROSCOPY CONTROLLED SCREW-TIP AUGMENTATION. ALL PATIENTS WERE IMPLANTED WITH A PHILOS PLATE. TWENTY-TWO PATIENTS UNDERWENT RSA WHILE 38 PATIENTS UNDERWENT STA USING CANNULATED SCREWS AND AUGMENTATION WAS THEN PERFORMED USING POLYMETHYLMETHACRYLATE (PMMA, TRAUMA CEM V+®, DEPUY SYNTHES GMBH, ZUCHWIL, SWITZERLAND OR CALCIUM PHOSPHATE CEMENT, QUICKSET, ARTHREX INC., NAPLES, FL, USA) THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: STA 14 PATIENTS DIED WITHIN THE FOLLOW-UP PERIOD. 5 PATIENTS HAD REVISION SURGERY (2 REVISION OSTEOSYNTHESIS, 1 CASE OF CONVERSION TO RSA). 4 CASES HAD SECONDARY DISPLACEMENT >10°. 4 CASES HAD AVN. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN TRAUMA CEM V+. (FRACTURE, NECROSIS)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750433 UNK - BIOMATERIAL - CEMENT: TRAUMACEM POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT LOD SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention