BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXLE SMALL

    MDR report key: 15315869 · Received August 29, 2022

    Report

    Report Number
    3008021110-2022-00069
    Event Type
    Malfunction
    Date Received
    August 29, 2022
    Date of Event
    April 29, 2022
    Report Date
    June 1, 2023
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    JDB
    Removal / Correction Number
    Z-1261-2023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SPECIFIC AXLE SMALL VERSION IMPLANTED (002) IS NOT 510K CLEARED: SHIPMENT OF THE COMPONENT AND SUBSEQUENT IMPLANTATION WAS A RESULT OF A HUMAN ERROR. THE COMPANY IS CURRENTLY TRYING TO RECOVER AS MUCH INFORMATION AS POSSIBLE TO PROMPTLY INVESTIGATE AND CORRECT THE ISSUE (CAPA TO BE PERFORMED). WE WILL SEND A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Additional Manufacturer Narrative · 0

    THE SPECIFIC AXLE SMALL VERSION IMPLANTED (002) IS NOT 510K CLEARED: SHIPMENT OF THE COMPONENT AND SUBSEQUENT IMPLANTATION WAS A RESULT OF A HUMAN ERROR. THE INTERNAL ANALYSIS HIGHLIGHTED THERE WAS A HUMAN ERROR IN SENDING A TOTAL OF N. 5 AXLE COMPONENTS WITH PRODUCT CODE 9159015010002 AFTER REQUESTS OF US MARKET TO HAVE N.5 AXLE COMPONENTS FOR PROCEEDING WITH STANDARD REVISION SURGERIES. THE DETAIL OF THE INVESTIGATION AND THE RELEVANT RISK ASSESSMENT ARE DESCRIBED IN THE DOCUMENT "VOLUNTARY ACTION TEMA ELBOW - PATIENT MONITORING ACTION" SHARED WITH THE FDA ON (B)(6) 2023. FDA RECALL NUMBER: Z-1261-2023 (LIMA REF. (B)(4) IN ADDITION TO THE PATIENT MONITORING ACTION, A CORRECTIVE ACTION AND PREVENTIVE ACTION (Q20230002) WAS OPENED TO REDUCE THE RISK OF RECURRENCE OF SIMILAR ISSUES, INCLUDING A SENSITIZATION TO MAKE THE INTERNAL OPERATORS AWARE OF THE IMPORTANCE TO CAREFULLY FOLLOW INTERNAL PROCEDURES. PMS DATA ACCORDING TO THE RELEVANT PMS DATA, A TOTAL OF 30 PIECES BELONGING TO PRODUCT CODE 9159015010002 WERE MADE AVAILABLE ON THE MARKET AND THREE OF THEM WERE IMPLANTED. COMPLETE TRACEABILITY GIVEN TO FDA THROUGH THE DOCUMENT "RATIONALE FOR VOLUNTARY RECALL". LIMA CORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. THIS IS A FINAL MDR.

    Description of Event or Problem · 0

    PATIENT UNDERWENT INITIAL SURGERY FOR TEMA ELBOW ON (B)(6) 2022. DURING THIS SURGERY THE FOLLOWING COMPONENTS HAVE BEEN IMPLANTED: ULNAR STEM #U6, ULNAR BODY SMALL, ULNAR LINER - SMALL, HUMERAL STEM #H7, AND HUMERAL BODY - SMALL. A REVISION SURGERY FOR UNKNOWN REASON WAS THEN PERFORMED ON (B)(6) 2022: EXISTING IMPLANTS WERE LINKED WITH A AXLE #SMALL, PRODUCT CODE 1590.15.010, LOT 2115522, STER 2100241. UNFORTUNATELY, THE COMMERCIAL CODE RELATED TO THE AXLE (1590.15.010) IS 510K CLEARED BUT THE SPECIFIC VERSION (002) OF THE PART IS NOT FDA CLEARED. EVENT HAPPENED IN US.

    Description of Event or Problem · 0

    PATIENT UNDERWENT INITIAL SURGERY FOR TEMA ELBOW ON (B)(6) 2022. DURING THIS SURGERY THE FOLLOWING COMPONENTS HAVE BEEN IMPLANTED: ULNAR STEM #U6, ULNAR BODY SMALL, ULNAR LINER - SMALL, HUMERAL STEM #H7, AND HUMERAL BODY - SMALL. A REVISION SURGERY FOR UNKNOWN REASON WAS THEN PERFORMED ON (B)(6) 2022: EXISTING IMPLANTS WERE LINKED WITH A AXLE #SMALL, PRODUCT CODE 1590.15.010, LOT 2115522, STER 2100241. UNFORTUNATELY, THE COMMERCIAL CODE RELATED TO THE AXLE (1590.15.010) IS 510K CLEARED BUT THE SPECIFIC VERSION (002) OF THE PART IS NOT FDA CLEARED. EVENT HAPPENED IN US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315262 AXLE SMALL AXLE SMALL JDB LIMACORPORATE S.P.A 1590.15.010 2115522

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Other