BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP LK SCR 3.5HEX 4.75X15 ST

    MDR report key: 9204370 · Received October 17, 2019

    Report

    Report Number
    0001825034-2019-04715
    Event Type
    Injury
    Date Received
    October 17, 2019
    Date of Event
    September 26, 2019
    Report Date
    March 25, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K132239
    Adverse Event
    Yes
    Product Problem
    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. FURTHER REVIEW HAS ESTABLISHED THAT ONLY TWO OF THE FOUR PERIPHERAL SCREWS FRACTURED. IT IS UNKNOWN WHICH SCREWS FRACTURED OF THE BELOW FOUR: COMP LK SCR 3.5HEX 4.75X30 ST CAT: 180553 LOT: 889270 STERILE EXP DATE: JUN 10, 2027 MFG DATE: JUN 10, 2017 UDI: (B)(4). COMP LK SCR 3.5HEX 4.75X15 ST CAT: 180550 LOT: 699000 STERILE EXP DATE: JAN 13, 2028 MFG DATE: JAN 13, 2018 UDI: (B)(4). COMP LK SCR 3.5HEX 4.75X40 ST CAT: 180555 LOT: 233830 STERILE EXP DATE: NOV 25, 2025 MFG DATE: NOV 25, 2015 UDI: (B)(4). COMP LK SCR 3.5HEX 4.75X20 ST CAT: 180551 LOT: 207730 STERILE EXP DATE: MAR 6, 2028 MFG DATE: MAR 6, 2018 UDI: (B)(4). VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THREE SCREWS ARE FRACTURED: 1 CENTRAL SCREW AND 2 OF THE PERIPHERAL SCREWS ARE FRACTURED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS 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.

    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: COMP RVS CNTRL 6.5X30MM ST/RST PN: 115396 LOT: 047530, COMP LK SCR 3.5HEX 4.75X30 ST PN: 180553 LOT: 889270, COMP LK SCR 3.5HEX 4.75X40 ST PN: 180555 LOT: 233830, COMP LK SCR 3.5HEX 4.75X20 ST PN: 180551 LOT: 207730, COMP RVRS 25MM BSPLT HA+ADPTR PN: 010000589 LOT: 111130, COMP RVSR SHLDR GLNSP +3 36MM PN: 115313 LOT: 239860, UNKNOWN TM STEM. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. 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 THE PATIENT WAS REVISED DUE TO IMPLANT FRACTURE AND SUBSEQUENT IMPLANT MIGRATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997761 COMP LK SCR 3.5HEX 4.75X15 ST SHOULDER, PROSTHESIS KWS ZIMMER BIOMET, INC. 699000

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R