BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LOW PRO CORT WASHER

    MDR report key: 8334967 · Received February 13, 2019

    Report

    Report Number
    0001825034-2019-00553
    Event Type
    Injury
    Date Received
    February 13, 2019
    Date of Event
    January 16, 2019
    Report Date
    August 23, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRS
    PMA / PMN Number
    K111663
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THAT THE HUMERAL 17H PLATE WAS FRACTURED AND DAMAGE WAS NOTED. TWO CANC LAG SCREWS ARE FRACTURED. ONE UNIDENTIFIED SCREW WAS BENT. THREE HEADS STRIPPED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: 3.5MM CORT LOCK SCR 54MM NS CAT: 816135054 LOT: UNK, 3.5MM CORT LOCK SCR 40MM NS CAT: 816135040 LOT: UNK, 3.5MM CORT LOCK SCR 22MM NS CAT: 816135022 LOT: UNK, 3.5MM CORT LOCK SCR 20MM NS CAT: 816135020 LOT: UNK, 3.5MM CORT LOCK SCR 20MM NS CAT: 816135020 LOT: UNK, 3.5MM CORT LOCK SCR 18MM NS CAT: 816135018 LOT: UNK, 3.5MM CORT LOCK SCR 18MM NS CAT: 816135018 LOT: UNK, 3.5MM CORT LOCK SCR 14MM NS CAT: 816135014 LOT: UNK, 3.5MM CORT LOCK SCR 12MM NS CAT: 816135012 LOT: UNK, 3.5MM CORT LOCK SCR 12MM NS CAT: 816135012 LOT: UNK, 3.5MM CORT LOCK SCR 10MM NS CAT: 816135010 LOT: UNK, 4.0MM CANC LAG SCR 60MM NS CAT: 815540060 LOT : UNK, 4.0MM CANC LAG SCR 35MM NS CAT: 815540035 LOT : UNK, CORTICAL SCREW 3.5 X 28MM CAT: 815037028 LOT: UNK, CORTICAL SCREW 3.5 X 26MM CAT: 815037026 LOT: UNK, CORTICAL SCREW 3.5 X 22MM CAT: 815037022 LOT: UNK, PLAIN WASHER 3PK CAT: 14460 LOT: UNK, DIS HUM POSTLAT LT 17H 147MM CAT: 131218308 LOT: UNK, 3.5MM LOW PROFILE CORT 30 MM CAT: 131218030 LOT: UNK, 3.5MM LOW PROFILE CORT 28 MM CAT: 131218028 LOT: UNK, 3.5MM LOW PROFILE CORT 28 MM CAT: 131218028 LOT: UNK, 3.5MM LOW PROFILE CORT 26 MM CAT: 131218026 LOT: UNK, 3.5MM LOW PROFILE CORT 22 MM CAT: 131218022 LOT: UNK, 3.5MM LOW PROFILE CORT 20 MM CAT: 131218020 LOT: UNK, 3.5MM LOW PROFILE CORT WASHER CAT: 131218000 LOT: UNK QTY: 3, 3.5MM LOW PROFILE CORT WASHER CAT: 131218000 LOT: SBM096175, 3.5MM LOW PROFILE CORT WASHER CAT: 131218000 LOT: SBM095295. (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-00553, 0001825034-2019-00551, 0001825034-2019-00550, 0001825034-2019-00549, 0001825034-2019-00548, 0001825034-2019-00547. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT ELBOW PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO POSTERIOR LATERAL PLATE FOUND TO BE FRACTURED UPON X-RAY INTRA-OPERATIVELY. IT WAS NOTED THAT PUS WAS ALSO FOUND. THE SURGEON REMOVED ALL OF THE COMPONENTS, PERFORMED A WASHOUT AND APPLIED AN EXTERNAL FIXATION DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129118 3.5MM LOW PRO CORT WASHER PLATE, FIXATION HRS ZIMMER BIOMET, INC. SBM095295

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R