BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: PHILOS PLATE

    MDR report key: 24904943 · Received April 16, 2026

    Report

    Report Number
    8030965-2026-03542
    Event Type
    Injury
    Date Received
    April 16, 2026
    Date of Event
    November 12, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: JAEKEL C, OEZEL L, LEIBNITZ F, WILMS LM, WINDOLF J, GEHRMANN SV, SCHOLZ AO. CLINICAL OUTCOME AND QUALITY OF LIFE AFTER MODULAR REVERSE TOTAL SHOULDER ARTHROPLASTY IN COMPARISON WITH JOINT-PRESERVING LOCKING PLATE OSTEOSYNTHESIS IN AGED PATIENTS: A RETROSPECTIVE COMPARISON STUDY. ORTHOP SURG. 2025 JAN;17(1):224-232. DOI: 10.1111/OS.14236. EPUB 2024 NOV 12. PMID: 39529573; PMCID: PMC11735364. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS STUDY WAS TO COMPARE THE CLINICAL FUNCTION AND PATIENT OUTCOME IN TERMS OF RANGE OF MOTION (ROM), ACTIVITIES OF DAILY LIVING (ADL), AS WELL AS PAIN ASSESSMENT AND REVISION RATE IN PHF OF AGED PATIENTS TREATED BY REVERSE SHOULDER ARTHROPLASTY (RSA) OR BY OPEN REDUCTION AND INTERNAL FIXATION (ORIF). FROM NOVEMBER 2011 TO MARCH 2016, 34 PATIENTS (17 MATCHED PAIRS; 31 FEMALES (91.2%) AND 3 MALES (8.8%) THAT HAD UNDERGONE EITHER ORIF OR RSA OF THE PROXIMAL HUMERUS, WERE INCLUDED IN THIS STUDY. THE MEAN AGE AT THE TIME OF SURGERY WAS 76.6 YEARS (SD 6.1) IN THE ENTIRE PATIENT POPULATION WITH NO SIGNIFICANT DIFFERENCE OBSERVED BETWEEN THE TWO GROUPS (RSA: 77.8 YEARS, SD 5.9; ORIF 75.3 YEARS, SD 6.3). FOR TOTAL SHOULDER REPLACEMENT, A REVERSE MODULAR SYSTEM (SMR, SISTEMA MODULARE RANDELLI, LIMA CORPORATE®, SAN DANIELE DEL FRIULI, ITALY) WAS USED. ORIF WAS PERFORMED BY LOCKING PLATE OSTEOSYNTHESIS (PHILOS® PLATE, DEPUY SYNTHES GMBH, SWITZERLAND). MEAN FOLLOW-UP PERIOD IS 1 YEAR. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES PHILOS®. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: PHILOS PLATE/SCREWS (QTY 4): (N=2) HUMERAL HEAD NECROSIS; UNDERWENT REVERSE SHOULDER ARTHROPLASTY (N=1) BEGINNING NECROSIS OF THE HUMERAL HEAD WITH COMPLETE REMOVAL OF THE OSTEOSYNTHESIS MATERIAL. (N=1) FAILED REDUCTION OF THE OSTEOSYNTHESIS; UNDERWENT REVERSE SHOULDER ARTHROPLASTY. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - SCREWS: PHILOS (QTY 3): (N=2) INTRAARTICULAR SCREW POSITION WITH REMOVAL OF THOSE SCREWS. (N=1) IMPINGEMENT CAUSED BY UNFAVORABLE SCREW POSITIONING WITH COMPLETE REMOVAL OF THE OSTEOSYNTHESIS MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123142 UNK - CONSTRUCTS: PHILOS PLATE PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1