BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: PHILOS

    MDR report key: 24931203 · Received April 20, 2026

    Report

    Report Number
    8030965-2026-03621
    Event Type
    Injury
    Date Received
    April 20, 2026
    Date of Event
    March 1, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    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.

    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. H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS (B)(4) (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. INVESTIGATION SUMMARY ==> PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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. 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: CREPAZ-EGER U, DANKL L, KNIERZINGER D, HENGG C. POSTOPERATIVE TREATMENT OF PROXIMAL HUMERUS FRACTURES WITH AN EARLY ACTIVE MOTION PROTOCOL: A PROSPECTIVE RANDOMIZED CONTROLLED TRAIL. J SHOULDER ELBOW SURG. 2025 OCT;34(10):2303-2310. DOI: 10.1016/J.JSE.2025.01.042. EPUB 2025 MAR 1. PMID: 40032060. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF OUR STUDY WAS TO INVESTIGATE THE FUNCTIONAL RESULTS OF A NOVEL EARLY ACTIVE MOTION REHABILITATION PROTOCOL FOR POSTOPERATIVE TREATMENT OF PROXIMAL HUMERUS FRACTURES TREATED WITH A LOCKING PLATE. FROM (B)(6), 2016, TO (B)(6), 2023, PATIENT WERE PROSPECTIVELY SCREENED FOR INCLUSION. INCLUSION CRITERIA WERE AS FOLLOWS: PROXIMAL HUMERUS FRACTURE (2-, 3-, AND 4-PART FRACTURES), ORIF WITH A LOCKING PLATE (PHILOS; SYNTHES GMBH, OBERDORF, SWITZERLAND) AND WITH AN AGE OF = 18 YEARS. PATIENTS WHO MET THE INCLUSION CRITERIA AND WERE WILLING TO PARTICIPATE WERE ANONYMIZED AND RANDOMLY ASSIGNED IN ONE OF 2 GROUPS. RANDOMIZATION RESULTED IN 20 PATIENTS IN THE CG AND 20 PATIENTS IN THE EFG. MEAN AGE WAS 58 YEARS (RANGE 26-77, SD 13.2) IN THE CG AND 64 YEARS (RANGE 50-77, SD 7.9) IN THE EFG, RESPECTIVELY. ALL PATIENTS WERE RIGHT-HANDED. IN THE CG, 6 PATIENTS WERE MALE AND 14 WERE FEMALE, WHEREAS IN THE EFG, 3 PATIENTS WERE MALE AND 17 WERE FEMALE. IN THE CONVENTIONAL GROUP (CG), PATIENTS UNDERWENT A STRICT POSTOPERATIVE PROTOCOL WITH IMMOBILIZATION IN A SHOULDER ARM SLING FOR 4 WEEKS, WHICH SHOULD BE WORN DAY AND NIGHT. IN THE EARLY FUNCTIONAL GROUP (EFG), NO RESTRICTIONS REGARDING MOVEMENT WERE GIVEN. THE SHOULDER-ARM SLING WAS ONLY USED FOR PAIN REDUCTION AND PATIENTS WERE ALLOWED TO TAKE THE SLING OFF AT ANY TIME. THE FOLLOW-UP PERIOD WAS 24 MONTHS FOR EACH PATIENT. 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 9): (N=5) AVASCULAR NECROSIS OF THE HUMERAL HEAD; 4 PATIENTS UNDERWENT REVISION SURGERY (N=1) DEEP INFECTION; UNDERWENT REVISION (N=1) LIMITATIO MOBILITAS; UNDERWENT REVISION SURGERY (N=1) IMPINGEMENT SYNDROME; UNDERWENT REVISION SURGERY (N=1) ADHESIVE CAPSULITIS; UNDERWENT REVISION SURGERY. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - SCREWS: PHILOS (QTY (B)(4): (N=1) LOOSENING OF THE SCREWS; UNDERWENT REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92561 UNK - SCREWS: PHILOS SCREW, FIXATION, BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1