BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVISION MODULAR STEM Ø20MM

    MDR report key: 13277781 · Received January 18, 2022

    Report

    Report Number
    3008021110-2022-00001
    Event Type
    Injury
    Date Received
    January 18, 2022
    Date of Event
    December 27, 2021
    Report Date
    May 23, 2022
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LZO
    PMA / PMN Number
    K151739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE DHR OF THE INVOLVED LOT #1106639, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS THAT WERE RELEASED ON THE MARKET WITH THE SAME LOT #. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT #. WE WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION WILL BE COMPLETED.

    Additional Manufacturer Narrative · 0

    THE SUSPECTED PRODUCT WAS NEVER MARKETED IN THE USA. THE INITIAL REPORT WAS ERRONEOUSLY FILED. BASED ON THE PERFORMED INVESTIGATIONS AND REVIEWING THE DEVICE HISTORY RECORDS, NO ANOMALIES WERE FOUND ON THE TOTAL NUMBER OF COMPONENTS MANUFACTURED WITH THE INVOLVED LOT #1106639. THE ANALYSIS ON THE EXPLANTED STEM FOUND NO DEFECTS NOR INCLUSIONS IN THE FRACTURE STARTING-AREA, NOR ON THE MATERIAL.

    Description of Event or Problem · 0

    HIP REVISION SURGERY PERFORMED ON (B)(6) 2021, DUE TO BREAKAGE OF THE TAPER OF THE REVISION MODULAR STEM Ø20MM (PRODUCT CODE 3816.15.020, LOT #1106639 - STER. 1100200). THE FOLLOWING COMPONENTS WERE REMOVED AND REPLACED: REVISION MODULAR STEM Ø20MM (PRODUCT CODE 3816.15.020, LOT #1106639 - STER. 1100200). FEMORAL MODULAR HEAD - S Ø32MM (PRODUCT CODE 5010.09.321, LOT #1010245 - STER. 1000261). REVISION MODULAR NECK H.60MM (PRODUCT CODE 7515.15.010, LOT #1200614 - STER. 1200040). PATIENT IS A MALE. IT WAS REPORTED HE HAS A NORMAL BMI. ACCORDING TO THE COMPLAINT SOURCE, PATIENT PERFORMS NORMAL ACTIVITY LEVEL. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2012. EVENT HAPPENED IN (B)(6).

    Description of Event or Problem · 0

    REVISION SURGERY OF THE RIGHT HIP PERFORMED ON (B)(6), 2021, DUE TO BREAKAGE OF THE TAPER OF THE REVISION MODULAR STEM Ø20MM (PRODUCT CODE 3816.15.020, LOT #1106639 - STER. 1100200). THE FOLLOWING COMPONENTS WERE REMOVED AND REPLACED: · REVISION MODULAR STEM Ø20MM (PRODUCT CODE 3816.15.020, LOT #1106639 - STER. 1100200). · FEMORAL MODULAR HEAD - S Ø32MM (PRODUCT CODE 5010.09.321, LOT #1010245 - STER. 1000261). · REVISION MODULAR NECK H.60MM (PRODUCT CODE 7515.15.010, LOT #1200614 - STER. 1200040). PREVIOUS SURGERY TOOK PLACE ON (B)(6), 2012. PATIENT IS A MALE. HE IS 77. HE IS 1.82M TALL AND WEIGHS 73KG. ACCORDING TO THE COMPLAINT SOURCE, PATIENT PERFORMS NORMAL ACTIVITY LEVEL. THE PATIENT HAS BILATERAL LIMACORPORATE REVISION STEM IMPLANTS. THE PROSTHESIS ON HIP'S LEFT SIDE (ORIGINALLY A COMPETITOR'S CEMENTED STEM) WAS FIRST REVISED IN 2012. A REVISION STEM WAS IMPLANTED THEN, AND SUCCESSIVELY REVISED IN 2013 DUE TO SUBSIDENCE. IT WAS REPORTED THAT A LONGER BODY REVISION STEM WAS IMPLANTED IN 2013. EVENT HAPPENED IN NEW ZEALAND. PLEASE NOTE THAT THE STEM INVOLVED IN THIS COMPLAINT BELONGS TO A VERSION THAT WAS NEVER MARKETED IN THE USA. THE INITIAL REPORT WAS ERRONEOUSLY FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217741 REVISION MODULAR STEM Ø20MM REVISION STEM DIA. 20 MM, L. 200 MM LZO LIMACORPORATE S.P.A. 3816.15.020 1106639

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention