BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: PHILOS

    MDR report key: 11959980 · Received June 8, 2021

    Report

    Report Number
    8030965-2021-04677
    Event Type
    Injury
    Date Received
    June 8, 2021
    Report Date
    May 14, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN PHILOS SCREW/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K 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 · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: KIM D-Y, KIM T-Y, HWANG J-T, PHILOS PLATE FIXATION WITH POLYMETHYL METHACRYLATE CEMENT, CLIN SHOULDER ELBOW, VOLUME 23 (3), PAGES 156-158, (SOUTH KOREA). THIS STUDY PRESENTS A CASE OF POLYMETHYL METHACRYLATE (PMMA) CEMENT AUGMENTATION IN A FAILED OSTEOPOROTIC PROXIMAL HUMERUS FRACTURE. A (B)(6) YEAR-OLD FEMALE WAS SENT TO THE EMERGENCY DEPARTMENT AFTER A FALL IN WHICH SHE LANDED ON HER LEFT ARM. THE PATIENT COMPLAINED ABOUT LEFT SHOULDER PAIN, SWELLING AND ECCHYMOSIS. ANTEROPOSTERIOR X-RAY AND COMPUTED TOMOGRAPHY OF THE LEFT SHOULDER SHOWED A 2-PART SURGICAL NECK FRACTURE OF THE PROXIMAL HUMERUS. AT 3 DAYS AFTER THE INJURY, AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) WAS PERFORMED WITH THE UNKNOWN SYNTHES PROXIMAL HUMERUS INTERNAL LOCKING SYSTEM PLATE AND SCREWS. ON POSTOPERATIVE DAY 4, THE PATIENT FELL FROM HER BED, AND THERE WAS SCREW BACK-OUT AND REDUCTION LOSS AT THE HUMERAL HEAD. A REVISIONAL ORIF WAS DONE ON POSTOPERATIVE DAY 7 AND THE PREVIOUS LOCKING PLATE WAS REMOVED. AFTER THE REVISIONAL ORIF WITH A PHILOS PLATE AND SCREWS, INCLUDING A LONG CALCAR SCREW, A METAPHYSEAL DEFECT DEVELOPED. A POLYMETHYL METHACRYLATE (PMMA) CEMENT WAS PLACED IN THE VOID AREA TO FILL THE DEFECT AND PROVIDE STRUCTURAL STABILITY. AN ABDUCTOR BRACE WAS APPLIED. THE POSTOPERATIVE X-RAY SHOWED FIRM FIXATION WITH THE PHILOS PLATE AND CEMENT AUGMENTATION. AFTER 4 WEEKS OF IMMOBILIZATION, THE BRACE WAS REMOVED, AND THE PATIENT STARTED EXERCISE TO INCREASE THE RANGE OF MOTION OF THE SHOULDER JOINT. AT THAT TIME, A FOLLOW-UP X-RAY SHOWED HEALING OF THE FRACTURE WITHOUT SCREW BACKOUT OR LOSS OF REDUCTION. AT 3 MONTHS AFTER THE REVISION OPERATION, THE PATIENT¿S RANGE OF MOTION WAS WITHIN THE NORMAL RANGE AND THE FUNCTION OF HER SHOULDER WAS IMPROVED. FINALLY, 6 MONTHS AFTER THE REVISION OPERATION, THE PATIENT WAS PAIN-FREE WITH FULL RANGE MOVEMENT OF THE LEFT SHOULDER AND IMPROVED CLINICAL OUTCOMES. X-RAYS REVEALED UNION OF THE PROXIMAL HUMERUS FRACTURE WITH NO SIGN OF AVASCULAR NECROSIS OF THE HUMERAL HEAD. THIS REPORT IS FOR THE UNKNOWN SYNTHES PROXIMAL HUMERUS INTERNAL LOCKING SYSTEM (PHILOS) SCREW. IT CAPTURES THE REPORTED SCREW BACK-OUT AND REDUCTION LOSS. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856033 UNK - SCREWS: PHILOS SCREW, FIXATION, BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention