BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMR FINNED HUMERAL BODY

    MDR report key: 16596539 · Received March 23, 2023

    Report

    Report Number
    3008021110-2023-00024
    Event Type
    Malfunction
    Date Received
    March 23, 2023
    Date of Event
    November 29, 2022
    Report Date
    March 15, 2023
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    HSD
    PMA / PMN Number
    K101263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BY THE CHECK OF THE DEVICE HISTORY RECORDS, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE 60 HUMERAL BODIES RELEASED WITH LOT 1802875 STER. 1800105. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT NUMBER (1802875). FURTHER INFORMATION WAS REQUESTED TO THE COMPLAINT SOURCE, SPECIFICALLY, CODE AND LOT NUMBER OF THE INSTRUMENT INVOLVED, CONSEQUENCE OF THE ISSUE, SUCH AS PROLONGATION OF THE SURGICAL TIME, AVAILABLE X-RAYS, INSTRUMENT RETURN FOR TESTING. THE REQUESTED DETAILS WERE NEVER PROVIDED; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. BASED ON THE CHECK OF THE DEVICE HISTORY RECORDS, WHICH CONFIRMED THE ABSENCE OF PRE-EXISTING ANOMALIES ON THE HUMERAL BODY UNDER ASSESSMENT, WE CLASSIFY THE EVENT AS NOT PRODUCT RELATED. PMS DATA: THIS IS THE FIRST AND ONLY SIMILAR COMPLAINT REGISTERED ON SMR ANATOMIC HUMERAL BODIES FAMILY CODES 1350.15.XXX, THE OCCURRENCE RATE IS THEREFORE ABOUT 0.002% NO CORRECTIVE ACTION NEEDED FOLLOWING THIS COMPLAINT. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR EVENT.

    Additional Manufacturer Narrative · 0

    BY THE CHECK OF THE DEVICE HISTORY RECORDS, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE (B)(4) HUMERAL BODIES RELEASED WITH LOT 1802875 STER. 1800105. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT NUMBER (182875). WE WILL SUBMIT A FINAL REPORT AFTER THE FINAL INVESTIGATION.

    Description of Event or Problem · 0

    INTRA-OPERATIVE ISSUE OCCURRED ON (B)(6) 2022: DURING SHOULDER SURGERY, THE HUMERAL INSERTER (CODE AND LOT NOT KNOWN) DID NOT FIT ON THE HUMERAL BODY WITH CODE 1350.15.110, LOT 1802875, STER. 1800105. THE COMPLAINT SOURCE REPORTED THAT THE HUMERAL BODY WAS EVENTUALLY IMPLANTED TRUSTING THE MORSE CONNECTION BETWEEN THE STEM AND THE HUMERAL BODY. PATIENT DATA: MALE, 59 YEARS OLD. THIS EVENT OCCURRED IN SPAIN.

    Description of Event or Problem · 0

    INTRA-OPERATIVE ISSUE OCCURRED ON (B)(6) 2022: DURING SHOULDER SURGERY, THE HUMERAL INSERTER (CODE AND LOT NOT KNOWN) DID NOT FIT ON THE HUMERAL BODY WITH CODE 1350.15.110, LOT 1802875, STER. 1800105. THIS EVENT OCCURRED IN SPAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427362 SMR FINNED HUMERAL BODY SMR FINNED HUMERAL BODY HSD LIMACORPORATE S.P.A. 1350.15.110 1802875

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization