BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANN, PROXIMAL HUMERUS, LEFT, 9X160MM

    MDR report key: 15092242 · Received July 25, 2022

    Report

    Report Number
    0009613350-2022-00389
    Event Type
    Injury
    Date Received
    July 25, 2022
    Date of Event
    July 5, 2022
    Report Date
    October 5, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    UDI-DI
    00889024505810
    PMA / PMN Number
    K200814
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MEDICAL DEVICES: BLUNT TIP SCREW, 4X36MM; ITEM# 47-2486-036-40; LOT# 3068947. BLUNT TIP SCREW, 4X38MM; ITEM# 47-2486-038-40; LOT# 3076829. BLUNT TIP SCREW, 4X38MM; ITEM# 47-2486-038-40; LOT# 3078220. ANN BLUNT TIP SCREW 4X56MM; ITEM# 47-2486-056-40; LOT# 3091269. ANN CORT BONE SCREW 4 X 24MM; ITEM# 47-2486-124-40; LOT# 3080024. ANN CORT BONE SCREW 4 X 28MM; ITEM# 47-2486-128-40; LOT# 3081901. AFFIXUS PH NL CAP 10.5X2.5MM; ITEM# 47-2488-010-02; LOT# 3048838. REPORT SOURCE ¿ FOREIGN: JAPAN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350 - 2022 ¿ 00390, 0009613350 - 2022 ¿ 00391, 0009613350 - 2022 ¿ 00392. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6. AS NO PRODUCT WAS RETURNED, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. DEVICES ARE USED FOR TREATMENT. MEDICAL RECORDS WERE NOT PROVIDED. THE INVESTIGATION DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). BASED ON THE AVAILABLE INFORMATION IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THIS ISSUE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROXIMAL SCREWS WERE BACKED OUT FROM THE PROPER POSITION AFTER 3 WEEKS FROM THE INITIAL SURGERY. NO REVISION IS PLANNED SO FAR. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89331 ANN, PROXIMAL HUMERUS, LEFT, 9X160MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3079658 00889024505810

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other SEE H10 NARRATIVE.