BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS SMOOTH STM W/SRW 150BW-13

    MDR report key: 13402848 · Received January 31, 2022

    Report

    Report Number
    0001825034-2022-00233
    Event Type
    Injury
    Date Received
    January 31, 2022
    Date of Event
    December 30, 2021
    Report Date
    February 28, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    K002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MEDICAL DEVICES: OSS 5CM DIAPHYSEAL SEGMENT: CATALOG#: 150465, LOT#: 559280; OSS 7CM SEGMENTAL FEMORAL RT: CATALOG#: 150354, LOT#: 626020; OSS AVL POLY TIB BUSHING SET: CATALOG#: 161071, LOT#: 944200; OSS POLY FEMORAL BUSHINGS: CATALOG#: 150477, LOT#: 159530; OSS AVL TIBIAL LOCK RING: CATALOG#: 161073, LOT#: 083450; OSS AXLE: CATALOG#: 150480, LOT#: 983170; OSS POLY LOCK PIN: CATALOG#: 150478, LOT#: 072120; OSS AVL YOKE 12MM: CATALOG#: 161075, LOT#: 071460; OSS AVL TIB BEARING 12MM: CATALOG#: 161068, LOT#: 313140. 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

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS CONFIRMS IMPLANT STEM FRACTURE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS/THESE ITEM(S) AND THE REPORTED PART AND LOT COMBINATION(S). 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

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT KNEE REVISION DUE TO FRACTURE OF THE STEM. NO FURTHER INFORMATION IS AVAILABLE.

    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
    1642136 OSS SMOOTH STM W/SRW 150BW-13 PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 008120

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H SEE H10.