BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMR SHOULDER

    MDR report key: 11649016 · Received April 12, 2021

    Report

    Report Number
    3008021110-2021-00029
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    February 23, 2021
    Report Date
    September 27, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWT
    UDI-DI
    08033390023016
    PMA / PMN Number
    K100858
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION BY CHECKING THE DHR OF THE LOT NUMBER 17AF00X AND THE LOT NUMBER 14AA370, NO PRE-EXISTING ANOMALIES WERE DETECTED ON THE PIECES MANUFACTURED WITH THESE LOT NUMBERS. THE INSTRUMENTS WERE AVAILABLE TO BE RETURNED FOR INSPECTION. THE INTERNAL ANALYSIS PERFORMED HIGHLIGHTED THAT THE THREAD OF THE TRIAL STEM IS WORN, AND THEREFORE THE TWO COMPONENTS SEIZED. THIS LEADS TO CONCLUDE THAT THE TRIAL STEM HAD BEEN USED MULTIPLE TIMES, CAUSING THE THREAD TO BECOME WORN. HENCE, CONSIDERING THAT: - NO PRE-EXISTING ANOMALY HAS BEEN DISCOVERED BY CHECKING THE MANUFACTURING CHARTS OF THE LOT NUMBERS INVOLVED IN THE EVENT - DURING THE INTERNAL ANALYSIS, THE THREAD OF THE TRIAL STEM WAS FOUND TO BE WORN, PROBABLY DUE TO MULTIPLE USES, AND THIS CAUSED THE COMPONENTS TO SEIZE. WE CAN CONCLUDE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA ACCORDING TO THE RELEVANT PMS DATA, WE CAN ESTIMATE THE OCCURRENCE RATE OF MALFUNCTIONING OF SMR - TRIAL FINNED STEMS BELONGING TO THE PRODUCT CODES 9013.04.110, 9013.04.120, 9013.04.130 TO BE AROUND 0,85% WORLDWIDE. PLEASE NOTE THAT THIS OCCURRENCE RATE IS OVERESTIMATED BECAUSE IT DOES NOT CONSIDER THE REUSE OF THE INSTRUMENTS BUT ONLY THE TOTAL NUMBER OF PIECES MANUFACTURED. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL MDR.

    Description of Event or Problem · 0

    DURING SHOULDER SURGERY PERFORMED ON (B)(6) 2021, THE SMR - TRIAL FINNED STEM Ø13 (PART CODE 9013.04.130, LOT NUMBER 17AF00X) SEIZED INTO THE SMR - STEM EXTRACTOR (PART CODE 9013.02.301, LOT NUMBER 14AA370). ACCORDING TO THE REPORTED INFORMATION, SURGEON IMPLANTED THE FINAL STEM WITHOUT TRIALING. SURGERY PROLONGED OF 15 MINUTES. EVENT HAPPENED IN THE UNITED STATES.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHR OF THE LOT #17AF00X AND #14AA370, NO PRE-EXISTING ANOMALIES WERE DETECTED ON THE PIECES MANUFACTURED WITH THESE LOT #S. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    DURING SHOULDER SURGERY PERFORMED ON (B)(6) 2021, THE SMR - TRIAL FINNED STEM Ø13 (PRODUCT CODE 9013.04.130, LOT# 17AF00X) COLD WELDED INTO THE SMR - STEM EXTRACTOR (PRODUCT CODE 9013.02.301, LOT# 14AA370). ACCORDING TO THE REPORTED INFORMATION, SURGEON IMPLANTED THE FINAL STEM WITHOUT TRIALING. SURGERY PROLONGED OF 15 MINUTES. EVENT HAPPENED IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551361 SMR SHOULDER FINNED TRIAL STEM DIA. 13MM KWT LIMACORPORATE S.P.A. 9013.04.130 17AF00X 08033390023016

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other