BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOW PROFILE SCREW

    MDR report key: 8353206 · Received February 20, 2019

    Report

    Report Number
    0001825034-2019-00687
    Event Type
    Injury
    Date Received
    February 20, 2019
    Date of Event
    October 6, 2015
    Report Date
    June 14, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K082446
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CATALOG NUMBER - 103534, LOT NUMBER - 3024981, EXPIRATION DATE - APR 30, 2023, MANUFACTURE DATE ¿ APR 15, 2013. OR THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER - 103531, LOT NUMBER - 2985156, EXPIRATION DATE - MAR 5, 2023, MANUFACTURE DATE ¿ MAR 5, 2013. OR THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER - 103531, LOT NUMBER - 3019393, EXPIRATION DATE - APR 8, 2023, MANUFACTURE DATE ¿ APR 8, 2013. CONCOMITANT MEDICAL PRODUCTS: PART: 103534, TI LOW PROFILE SCREW 6.5X35MM, LOT: 3024981, PART: 103531, TI LOW PROFILE SCREW 6.5X20MM, LOT: 2985156, PART: 103531, TI LOW PROFILE SCREW 6.5X20MM, LOT: 3019393, PART: 131352HA, EXC ABT RNGLC-X SHL HA/PC 052M, LOT: 2959304, PART: EP-043252, RINGLOC-X E1 STD 52/32MM, LOT: 2290670, PART: 131348HA, EXC ABT RNGLC-X SHL HA/PC 048M, LOT: 3112507, PART: EP-042848, RINGLOC-X E1 STD 48/28MM, LOT: 3143418. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) 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). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: PART#: UNK, UNK EXCEED CUP SIZE 50, LOT#: UNK; PART#: UNK, UNK EXCEED POLYETHYLENE INSERT SIZE 32, LOT#: UNK; PART#: UNK, HEAD CERAMIC SIZE 32, LOT#: UNK; PART#: UNK, GTS STANDARD STEM SIZE -2, LOT#: UNK. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL HIP PROCEDURE AND SUBSEQUENTLY, WAS REVISED DUE TO PAIN 15 MONTHS LATER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148984 TI LOW PROFILE SCREW HIP PROSTHESIS KWA ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R