BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: PHILOS

    MDR report key: 11967125 · Received June 9, 2021

    Report

    Report Number
    2939274-2021-02852
    Event Type
    Injury
    Date Received
    June 9, 2021
    Report Date
    May 17, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). THIS REPORT IS FOR AN UNK - SCREWS: PHILOS/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 AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. THE 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. 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: CHAN JM, ET AL. (2021) ARTHROSCOPIC-ASSISTED REMOVAL OF PROXIMAL HUMERUS LOCKING PLATES WITH CAPSULAR RELEASE SIGNIFICANTLY IMPROVES RANGE OF MOTION AND FUNCTION, ARTHROSCOPY, SPORTS MEDICINE, AND REHABILITATION, VOL 3, NO 1, PAGES E211-E2117, (USA) THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE THE CLINICAL OUTCOMES FOLLOWING THE ARTHROSCOPIC REMOVAL OF PROXIMAL HUMERUS LOCKING PLATES FOR SYMPTOMATIC HARDWARE AFTER OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF PROXIMAL HUMERUS FRACTURES. FROM JANUARY 2009 TO DECEMBER 2016, 88 PATIENTS WHO HAD PREVIOUSLY UNDERGONE ORIF FOR PROXIMAL HUMERUS FRACTURES WHO ELECTED TO UNDERGO REMOVAL OF PROXIMAL HUMERUS LOCKING PLATES WITH CAPSULAR RELEASE WERE INCLUDED IN THE STUDY. THERE WERE 22 MEN AND 66 WOMEN WITH A MEAN AGE OF 59+/-13.5. THE INITIAL ORIF WAS PERFORMED USING AN UNKNOWN SYNTHES PROXIMAL HUMERUS LOCKING PLATES. ALL PATIENTS THEN UNDERWENT ARTHROSCOPIC-ASSISTED REMOVAL OF PROXIMAL HUMERUS LOCKING PLATES. THE MEAN DURATION FROM PROXIMAL HUMERUS ORIF TO REMOVAL OF HARDWARE WAS 11.4 +/- 10.2 MONTHS (RANGE, 3.9-64.2 MONTHS). POSTOPERATIVE PROTOCOLS INVOLVED PATIENTS WEARING A SLING FOR COMFORT FOR THE FIRST 4 TO 6 WEEKS. AGGRESSIVE PASSIVE AND ACTIVE-ASSISTED RANGE OF MOTION IN ALL PLANES WERE INITIATED ON POSTOPERATIVE DAY 1. PATIENTS PROGRESSED TO STRENGTHENING EXERCISES AT WEEK 4. ALL PATIENTS WERE EVALUATED AT A MINIMUM OF 6 WEEKS POSTOPERATIVELY. THE MEAN TIME FROM ROH TO THE LATEST FOLLOW-UP WAS 4.7 +/- 7 MONTHS (RANGE, 1.5-52.4 MONTHS). COMPLICATIONS WERE REPORTED: 4 PATIENTS HAD AVASCULAR NECROSIS. 18 PATIENTS UNDERWENT REMOVAL OF HARDWARE DUE TO PAIN ONLY. 19 PATIENTS UNDERWENT REMOVAL OF HARDWARE DUE TO LACK OF RANGE OF MOTION ONLY. 50 PATIENTS UNDERWENT REMOVAL OF HARDWARE DUE TO BOTH PAIN AND LACK OF RANGE OF MOTION. 1 PATIENT UNDERWENT REMOVAL OF HARDWARE DUE TO INFECTION. ALL PATIENTS HAD PROMINENT HARDWARE SUPERIOR LATERALLY ON DIAGNOSTIC ARTHROSCOPY AND UNDERWENT AXILLARY NERVE NEUROLYSIS AT THE TIME OF THE REMOVAL OF HARDWARE, AS WELL AS CAPSULAR RELEASE AND SUBACROMIAL DECOMPRESSION. 5 PATIENTS HAD SECONDARY SCREW PERFORATIONS BASED ON DIRECT VIEW INTRA-ARTICULARLY WITH THE SCOPE. THIS REPORT IS FOR THE UNKNOWN SYNTHES LONG PROXIMAL HUMERUS INTERNAL LOCKING SYSTEM PLATE (PHILOS). A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT IS FOR (1)UNK - SCREWS: PHILOS. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863113 UNK - SCREWS: PHILOS SCREW, FIXATION, BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention