BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LOW PRO CORT WASHER

    MDR report key: 8332680 · Received February 12, 2019

    Report

    Report Number
    0001825034-2019-00550
    Event Type
    Injury
    Date Received
    February 12, 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 (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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). 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. REPORT SOURCE: FOREIGN ¿ (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT; PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-00553, 0001825034-2019-00551, 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
    124896 3.5MM LOW PRO CORT WASHER PLATE, FIXATION HRS ZIMMER BIOMET, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R