BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAL NECK WITH SCREW H=60MM

    MDR report key: 11862309 · Received May 21, 2021

    Report

    Report Number
    3008021110-2021-00040
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    April 15, 2021
    Report Date
    April 4, 2023
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LZO
    PMA / PMN Number
    K151739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BY CHECKING THE MANUFACTURING CHARTS OF LOT 19BG01Z, NO ANOMALIES WERE DETECTED ON THE PRODUCTS MANUFACTURED WITH THE SAME LOT NUMBER. BY CHECKING THE MANUFACTURING CHARTS OF LOT 2020621, NO ANOMALIES WERE DETECTED ON THE PRODUCTS MANUFACTURED WITH THE SAME LOT NUMBER. COMPONENTS ANALYSIS: THE INSTRUMENT AND THE STEM INVOLVED IN THE COMPLAINT WERE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. WE PERFORMED AN INTERNAL ANALYSIS, TRYING TO REPLICATE THE PROBLEM DESCRIBED IN THE COMPLAINT. THE FUNCTIONAL TESTS HIGHLIGHTED THAT THE TRIAL NECK WITH SCREW H=60MM SCREWED AND UNSCREWED CORRECTLY ON THE REVISION MODULAR STEM Ø21MM. THE SAME TEST WAS DONE USING ANOTHER TRIAL NECK, AND NO ANOMALY WAS FOUND. THE DIMENSIONAL CHECK PERFORMED ON BOTH THE INSTRUMENT (NECK AND SCREW) AND THE STEM HIGHLIGHTED NO ANOMALIES. CHECKING THE THREAD OF THE SCREW, IT DOESN'T SHOW ANY DAMAGE. BASED ON THE ANALYSIS PERFORMED, WE CAN SUPPOSE THAT THE SEIZURE BETWEEN THE COMPONENTS COULD HAVE BEEN CAUSED BY THE PRESENCE OF TISSUE OR DEBRIS. IN CONCLUSION: CHECKING THE MANUFACTURING CHARTS OF THE TWO LOT NUMBERS INVOLVED, NO ANOMALIES WERE FOUND. THE INTERNAL ANALYSIS AND TESTS PERFORMED DIDN'T SHOW ANY MALFUNCTION OR DAMAGE. THEREFORE, WE CAN SUPPOSE THAT THE PROBLEM EXPERIENCED WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO OUR PMS DATA, WE CAN ESTIMATE THE MALFUNCTIONING OCCURRENCE RATE OF THE INSTRUMENT TRIAL NECK WITH SCREW TO BE ABOUT 0,01% 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. 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. THIS IS A FINAL MDR.

    Description of Event or Problem · 0

    DURING HIP SURGERY PERFORMED ON (B)(6) 2021, THE TRIAL NECK WITH SCREW H=60MM (PRODUCT CODE 9038.10.660, LOT NUMBER 19BG01Z) GOT STUCK INTO THE REVISION MODULAR STEM Ø21MM (PRODUCT CODE 3817.15.020, LOT NUMBER 2020621). CONSEQUENTLY, DURING THE REDUCTION THE BONE WAS FRACTURED. THE SURGERY WAS CONCLUDED USING A REVISION LR STEM. THE PATIENT IS A FEMALE, 83 YEARS OLD. EVENT HAPPENED IN ITALY.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE MANUFACTURING CHARTS OF LOT #19BG01Z, NO ANOMALIES WERE DETECTED ON THE PRODUCTS MANUFACTURED WITH THE SAME LOT #. BY CHECKING THE MANUFACTURING CHARTS OF LOT #2020621, NO ANOMALIES WERE DETECTED ON THE PRODUCTS MANUFACTURED WITH THE SAME LOT #. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    DURING HIP SURGERY PERFORMED ON (B)(6) 2021, THE TRIAL NECK WITH SCREW H=60MM (PRODUCT CODE 9038.10.660, LOT# 19BG01Z) GOT STUCK INTO THE REVISION MODULAR STEM Ø21MM (PRODUCT CODE 3817.15.020, LOT# 2020621). CONSEQUENTLY, DURING THE REDUCTION THE BONE WAS FRACTURED. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761233 TRIAL NECK WITH SCREW H=60MM TRIAL NECK H60 WITH SCREW LZO LIMACORPORATE S.P.A. 9038.10.660 19BG01Z

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other