BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMAL HUMERUS, RIGHT, ÿ 11X160MM

    MDR report key: 18184684 · Received November 21, 2023

    Report

    Report Number
    0009613350-2023-00643
    Event Type
    Malfunction
    Date Received
    November 21, 2023
    Date of Event
    October 16, 2023
    Report Date
    December 7, 2023
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    PMA / PMN Number
    K200814
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. UPDATED: D4(UDI); E1; E2; E3; G3; H2; H3; H6. H6: INVESTIGATION FINDINGS: MALFUNCTION OBSERVED. TWO RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. TWO VIEWS OF THE RIGHT HUMERUS DEMONSTRATE AN INTRAMEDULLARY ROD WITH MULTIPLE FIXATION SCREW; THE PROXIMAL TWO FIXATION SCREWS HAVE WITHDRAWN. COMMINUTED FRACTURE OF THE PROXIMAL HUMERAL DIAPHYSIS WITH LUCENT FRACTURE LINE STILL SEEN. GLENOID OSTEOPHYTOSIS AND STEOPENIA. OVERALL FIT AND ALIGNMENT OF THE IMPLANTS IS APPROPRIATE. PERHAPS THE SCREWS BACKED OUT BECAUSE OF THE INCOMPLETELY HEALED FRACTURE. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. A DEFINITIVE ROOT CAUSE IS UNABLE TO BE DETERMINED IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D.10 BLUNT TIP SCREW, ÿ 4X44MM ITEM#47-2486-044-40, LOT#3076788. BLUNT TIP SCREW, ÿ 4X42MM ITEM#47-2486-042-40, LOT#3155804. ANN BLUNT TIP SCREW 4X42MM ITEM#47-2486-042-40, LOT#3152737. ANN BLUNT TIP SCREW 4X60MM ITEM#47-2486-060-40 ,LOT#3091607. ANN CORT BONE SCREW 4 X 30MM ITEM# 47-2486-130-40, LOT#3155767. ANN CORT BONE SCREW 4 X 32MM ITEM# 47-2486-132-40, LOT#3091574. AFFIXUS PH NL CAP 0MM ITEM#47-2488-010-00 LOT#3158999 G2. REPORT SOURCE: JAPAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: MEDWATCH'S: 0009613350-2023-00644 AND 0009613350-2023-00645.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT PRESENTED APPROXIMATELY 4 WEEKS POST INITIAL SURGERY AND IT WAS FOUND THAT TWO PROXIMAL SCREWS HAVE BACKED OUT OF THE ANN NAIL SYSTEM. AT THIS TIME, NO REVISION SURGERY IS PLANNED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OPERATION WAS PERFORMED WITH ANN NAIL ON (B)(6) 2023. AFTER 4 WEEKS FROM THIS SURGERY, SURGEON FOUND #1 AND #2 PROXIMAL SCREWS WERE BACKED OUT FROM THE PROPER POSITION. THE SURGEON KEEPS AN EYE ON THE PATIENT CONDITION AS WELL AS NO REVISION WILL BE PLANNED SO FAR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2045985 PROXIMAL HUMERUS, RIGHT, ÿ 11X160MM PROSTHESIS, TRAUMA HSB ZIMMER GMBH N/A 3137800

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown