BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXLE LARGE

    MDR report key: 16831045 · Received April 28, 2023

    Report

    Report Number
    3008021110-2023-00040
    Event Type
    Injury
    Date Received
    April 28, 2023
    Date of Event
    July 12, 2022
    Report Date
    January 30, 2024
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    JDB
    PMA / PMN Number
    K222807
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS FOUND ON THE DEVICES ASSOCIATED WITH THIS EVENT. THEREFORE, THE PRODUCTS WITH THESE LOT #S HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. THE ITEMS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMA CORPORATE FOR FURTHER ANALYSIS. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY NO PRE-OPERATIVE OR POST-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY WERE AVAILABLE. BASED ON THE INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THAT; CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALIES WERE FOUND ON THE DEVICES ASSOCIATED WITH THIS EVENT. IT WAS REPORTED PATIENT REQUIRED REVISION FROM INFECTION THAT WAS REPORTED AS NOT IMPLANT RELATED. WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA THE EVENT REPORTED BY COMPLAINT SOURCE IS LOOSENING OF A CUSTOMIZED HUMERAL IMPLANT. NO REVISION RATE IS TO BE PROVIDED SINCE CUSTOMIZED IMPLANTS ARE MANUFACTURED AS SINGLE PIECES. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMA CORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL MDR.

    Additional Manufacturer Narrative · 0

    WE WILL SUBMIT A FINAL MDR AFTER THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    REVISION SURGERY WAS PERFORMED ON (B)(6) 2022, DUE TO PAIN AND INFECTION. ALL IMPLANTS ARE REMOVED AND THERE IS NO PLAN FOR A REVISION AS OF NOW, DUE TO THE PATIENT'S BONE CONDITION. THE PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2021. PATIENT - FEMALE BIRTH DATE = (B)(6) 1964 HEIGHT = 62 IN. WEIGHT = 245LB EVENT HAPPENED IN U.S. EXPLANTED COMPONENTS. ULNAR BODY LARGE RIGHT + SCREW, COMMERCIAL CODE #155214021 - LOT #1815875 - STER. #2000051 ULNAR LINER - LARGE RIGHT, COMMERCIAL CODE #156050021 - LOT #18AT1RV - STER. #1900184 AXLE LARGE TEMA ELBOW - TI6AL4, COMMERCIAL CODE #159015020 - LOT #2106130 - STER. #2100140 CMD 18-1119 HUMERAL FLANGE LAT., COMMERCIAL CODE #961714603 - LOT #1907244 - STER. #1900164 CMD 18-1119 HUMERAL DIST. COMP, COMMERCIAL CODE #961799032 - LOT #1907243 - STER. #1900168 PATINET MEDICAL HISTORY ON (B)(6) 2020, THE SURGERY FOR THE IMPLANT OF CMD 18-1119 WAS PERFORMED. ON (B)(6) 2021, THE ULNAR COMPONENT (CODE 9617.99.033, REF. CMD 18-1119) FAILED DUE TO LOOSENING OF THE IMPLANT AND DRILLING OF THE ULNA. NEW PROMADE CASE WAS CREATED (CMD 21-1147) TO REPLACE THE ULNAR. ON (B)(6) 2021: REVISION SURGERY PERFORMED DUE TO LOOSENING. COMPASSIONATE DEVICE CMD 21-1147 IMPLANTED DURING THE REVISION SURGERY. REGISTERED INTERNALLY AS COMPLAINT (B)(4) . ON (B)(6) 2022, REVISION SURGERY PERFORMED DUE TO PAIN AND INFECTION. ALL IMPLANTS ARE REMOVED AND THERE IS NO PLAN FOR A REVISION. (OBJECT OF THIS REPORT)

    Description of Event or Problem · 0

    REVISION SURGERY WAS PERFORMED ON (B)(6) 2022, DUE TO PAIN AND INFECTION. ALL IMPLANTS ARE REMOVED AND THERE IS NO PLAN FOR A REVISION AS OF NOW, DUE TO THE PATIENT'S BONE CONDITION. THE PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2021. PATIENT - FEMALE. BIRTH DATE = (B)(6) 1964. HEIGHT = 62 IN. WEIGHT = 245LB. EVENT HAPPENED IN U.S. EXPLANTED COMPONENTS. ULNAR BODY LARGE RIGHT + SCREW, COMMERCIAL CODE #155214021 - LOT #1815875 - STER. #2000051. ULNAR LINER - LARGE RIGHT, COMMERCIAL CODE #156050021 - LOT #18AT1RV - STER. #1900184. AXLE LARGE TEMA ELBOW - TI6AL4, COMMERCIAL CODE #159015020 - LOT #2106130 - STER. #2100140. CMD 18-1119 HUMERAL FLANGE LAT., COMMERCIAL CODE #961714603 - LOT #1907244 - STER. #1900164. CMD 18-1119 HUMERAL DIST. COMP, COMMERCIAL CODE #961799032 - LOT #1907243 - STER. #1900168.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430323 AXLE LARGE AXLE LARGE JDB LIMACORPORATE S.P.A 1590.15.020 2106130

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention