BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: LOCKING

    MDR report key: 19817056 · Received July 24, 2024

    Report

    Report Number
    8030965-2024-09177
    Event Type
    Injury
    Date Received
    July 24, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    0
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. H11 ADDITIONAL NARRATIVE: D1, D2, D3, D4, G4 ¿ 510K: THIS REPORT IS FOR AN UNK - SCREWS: LOCKING/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: 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 COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: HRISTOV S, VISSCHER L, WINKLER J, ZHELEV D, IVANOV S, VESELINOV D, BALTOV A, VARGA P, BERK T, STOFFEL K, KRALINGER F, GUEORGUIEV B. A NOVEL TECHNIQUE FOR TREATMENT OF METAPHYSEAL VOIDS IN PROXIMAL HUMERUS FRACTURES IN ELDERLY PATIENTS. MEDICINA (KAUNAS). 2022 OCT 10;58(10):1424. DOI: 10.3390/MEDICINA58101424. PMID: 36295586; PMCID: PMC9611038. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS STUDY WAS TO ASSESS THE CLINICAL OUTCOMES AND COMPLICATION PROFILES OF THE NOVEL TECHNIQUE FOR POLYMETHYLMETHACRYLATE (PMMA) AUGMENTATION, COMPARED TO THE ILIAC CREST BONE GRAFT AUGMENTATION OR NO AUGMENTATION. BETWEEN 2018 TO 2021, A TOTAL OF 120 PATIENTS (11 MALE AND 109 FEMALE) WITH A MEAN AGE OF 66.6 YEARS WERE INCLUDED IN THE STUDY. THESE PATIENTS HAD PROXIMAL HUMERUS FRACTURE AND WERE TREATED BY A SINGLE SURGEON VIA OPEN REDUCTION AND INTERNAL FIXATION USING PHILOS PLATE (DEPUY SYNTHES). EACH PATIENT WAS OFFERED TREATMENT WITH EITHER NO AUGMENTATION, OR IF INDICATED, A METAPHYSEAL VOID WAS FILLED WITH AN AUTOLOGOUS BONE GRAFT OR PMMA-BASED BONE CEMENT USING TRAUMACEM (DEPUY SYNTHES) WHERE 63 PATIENTS HAD NO AUGMENTATION, WHILE 28 AND 29 PATIENTS HAD BONE GRAFT AUGMENTATION AND PMMA AUGMENTATION RESPECTIVELY. PATIENTS WERE FOLLOWED UP ON THE 3RD, 6TH, AND 12TH MONTH POST SURGERY. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UNKNOWN SYNTHES PHILOS PLATE AND UNKNOWN SYNTHES TRAUMACEM. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: PHILOS PLATE/SCREWS (QTY. 46): NO AUGMENTATION, (N=7) VARUS MALUNION, TREATMENT: NOT REPORTED, (N=3) GREATER TUBEROSITY RESORPTION, TREATMENT: NOT REPORTED, (N=5) SUBACROMIAL IMPINGEMENT, TREATMENT: NOT REPORTED, (N=6) ADHESIVE CAPSULITISE, TREATMENT: NOT REPORTED, (N=3) AVASCULAR NECROSIS (AVN), TREATMENT: NOT REPORTED, (N=1) INFECTION, TREATMENT: NOT REPORTED, (N=4) OTHER IMPLANT-RELATED COMPLICATIONS, TREATMENT: NOT REPORTED. BONE GRAFT AUGMENTATION, (N=2) VARUS MALUNION, TREATMENT: NOT REPORTED, (N=2) GREATER TUBEROSITY RESORPTION, TREATMENT: NOT REPORTED, (N=2) SUBACROMIAL IMPINGEMENT, TREATMENT: NOT REPORTED, (N=2) ADHESIVE CAPSULITISE, TREATMENT: NOT REPORTED, (N=3) AVASCULAR NECROSIS (AVN), TREATMENT: NOT REPORTED, (N=1) INFECTION, TREATMENT: NOT REPORTED, (N=2) OTHER IMPLANT-RELATED COMPLICATIONS, TREATMENT: NOT REPORTED. PMMA-BASED AUGMENTATION, (N=1) SUBACROMIAL IMPINGEMENT, TREATMENT: NOT REPORTED, (N=2) AVASCULAR NECROSIS (AVN), TREATMENT: NOT REPORTED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - SCREWS: LOCKING (QTY. 5): NO AUGMENTATION, (N=3) SCREW PERFORATION, TREATMENT: REOPERATION. BONE GRAFT AUGMENTATION, (N=2) SCREW PERFORATION, TREATMENT: REOPERATION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - BIOMATERIAL - CEMENT: TRAUMACEM (QTY. 3): PMMA-BASED AUGMENTATION, (N=1) SUBACROMIAL IMPINGEMENT, TREATMENT: NOT REPORTED, (N=2) AVASCULAR NECROSIS (AVN), TREATMENT: NOT REPORTED. THIS REPORT IS FOR UNK - SCREWS: LOCKING. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2363778 UNK - SCREWS: LOCKING SCREW,FIXATION,BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention