BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELBOW ULNAR STEM

    MDR report key: 13565530 · Received February 20, 2022

    Report

    Report Number
    3008021110-2022-00008
    Event Type
    Injury
    Date Received
    February 20, 2022
    Date of Event
    May 9, 2022
    Report Date
    April 9, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    JDB
    PMA / PMN Number
    K181362
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING RECORDS WERE CHECKED CONFIRMING THE BATCH NUMBER INVOLVED (LOT 1715495, STER. 1900181) WAS MANUFACTURED CORRECTLY UP TO SPECIFICATION AND IN-LINE WITH THE RELEVANT CHECKS AND TESTS. NO MANUFACTURING DEVIATIONS WERE REPORTED. NO OTHER COMPLAINTS RECEIVED ON A TOTAL OF 12 ITEMS MANUFACTURED WITH THE SAME LOT#. WE WILL SEND A FINAL INVESTAGATION REPORT ONCE THE REVISION SURGERY WILL BE PERFORMED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION MANUFACTURING RECORDS WERE CHECKED CONFIRMING THE BATCH NUMBER INVOLVED (LOT 1715495, STERILIZATION (B)(6)) WAS MANUFACTURED CORRECTLY UP TO SPECIFICATION AND IN-LINE WITH THE RELEVANT CHECKS AND TESTS. NO MANUFACTURING DEVIATIONS WERE REPORTED, THAT COULD HAVE CONTRIBUTED TO THE EVENT. THE INVOLVED IMPLANT WAS NOT AVAILABLE TO BE RETURNED. BASED ON THE FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THAT; - THE CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH THE INVOLVED LOT NUMBER. - THE PATIENT HAS EXPERIENCED MULTIPLE FRACTURES AND INSUFFICIENT BONE. WE CAN CONCLUDE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA ACCORDING TO THE PMS RECORDS, THIS IS THE FIRST AND ONLY COMPLAINT FOR ULNAR STEM BELONGING TO THE FAMILY CODE 1575.14.XXX, DUE TO BONE FRACTURE, SINCE GOING TO MARKET IN 2020. 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

    FRACTURE OF RADIUS BONE EXPERIENCED ON (B)(6) 2022. PATIENT'S CLINICAL HISTORY AS PER FOLLOWING: ORIGINAL SURGERY DONE ON (B)(6) 2021 TO IMPLANT CUSTOMIZED PROSTHESIS ON HUMERAL SIDE + VARIOUS TEMA ELBOW CLEARED COMPONENTS (CMD 21-1194); REVISION SURGERY PERFORMED ON (B)(6) 2021. DURING THE REVISION SURGERY, THE SURGEON PLACED THE ULNAR STEM ((B)(4), LOT 1715495 STER 1900181) INTO THE RADIUS AND REMOVED THE AXLE COMPONENT PREVIOUSLY IMPLANTED ((B)(4) CMD 21-1194 HUMERAL IMPLANT LOT 2117686 - STER. 210026. AXLE COMPONENT IS NOT IDENTIFIED BY A SINGLE PRODUCT CODE). EVENT WAS REGISTERED IN LIMA COMPLAINT DATABASE AS COMPLAINT #(B)(4), NOT REPORTED AS MDR BUT WITHIN THE EXPANDED ACCESS PROGRAM. ON (B)(6) 2022 ANOTHER FRACTURE WAS EXPERIENCED AND THIS HAPPENED IN THE RADIUS BONE (WHERE THE CLEARED ULNAR STEM (B)(4), LOT 1715495 STER 1900181 IS IMPLANTED). THE PATIENT ONLY HAS THE HUMERAL IMPLANT FIXATED AND THE ULNAR IMPLANT IS JUST SITTING IN THE SOFT TISSUE UNTIL A NEW CUSTOMIZED DEVICE (ALREADY REQUESTED BY THE SURGEON) WILL ADDRESS THE MULTIPLE FRACTURES AND INSUFFICIENT BONE. NO REVISION SURGERY PERFORMED TO DATE. LIMA WAS MADE AWARE OF THE DISLOCATION AND BONE FRACTURE BUT NOT THE DETAIL THAT LEAD TO THE CONDITION. THIS EVENT IS REGISTERED AS LIMACORPORATE COMPLAINT #(B)(4).

    Description of Event or Problem · 0

    ELBOW REVISION SURGERY PERFORMED ON (B)(6) 2022 DUE TO FRACTURE OF RADIUS BONE DISCOVERED ON (B)(6) 2022. THE COMPONENT EXPLANTED WAS THE FOLLOWING: ULNAR STEM #U5 (COMMERCIAL CODE 1575.14.010, LOT NUMBER 1715495, STERILIZATION (B)(6)) THE PATIENT IS A FEMALE, 72 YEARS OLD. PATIENT'S CLINICAL HISTORY AS PER FOLLOWING: ·ORIGINAL SURGERY DONE ON (B)(6) 2021, TO IMPLANT CUSTOMIZED PROSTHESIS ON HUMERAL SIDE ((B)(6)) AND VARIOUS TEMA ELBOW CLEARED COMPONENTS ON THE ULNAR SIDE. ·ON (B)(6) 2021, THE FIRST REVISION SURGERY WAS PERFORMED DUE TO PAIN AND ULNAR FRACTURE. DURING THE REVISION SURGERY, THE SURGEON PLACED THE ULNAR STEM (PRODUCT CODE 1575.14.010, LOT NUMBER 1715495, STERILIZATION (B)(6), ORIGINALLY IMPLANTED ON (B)(6) 2021) INTO THE RADIUS AND REMOVED THE AXLE COMPONENT PREVIOUSLY IMPLANTED. EVENT WAS REGISTERED IN LIMA COMPLAINT DATABASE AS COMPLAINT #(B)(4), NOT REPORTED AS MDR BUT WITHIN THE EXPANDED ACCESS PROGRAM (POSTOPERATIVE FOLLOW-UP REPORT FOR FDA COMPASSIONATE USE REQUEST (B)(4)). ·ON (B)(6) 2022, ANOTHER FRACTURE WAS EXPERIENCED, AND THIS HAPPENED IN THE RADIUS BONE (WHERE THE CLEARED ULNAR STEM CODE 1575.14.010, LOT 1715495 STERILIZATION (B)(6) WAS IMPLANTED). THE PATIENT ONLY HAS THE HUMERAL IMPLANT FIXATED AND THE ULNAR IMPLANT IS JUST SITTING IN THE SOFT TISSUE UNTIL A NEW CUSTOMIZED DEVICE (ALREADY REQUESTED BY THE SURGEON) WILL ADDRESS THE MULTIPLE FRACTURES AND INSUFFICIENT BONE. LIMACORPORATE WAS MADE AWARE OF THE DISLOCATION AND BONE FRACTURE BUT NOT THE DETAIL THAT LED TO THE CONDITION. ON (B)(6) 2022, THE SECOND REVISION SURGERY TOOK PLACE, AND A CUSTOMIZED RADIUS IMPLANT WAS PLACED IN ((B)(6)). ALONG WITH IT, A STANDARD ULNAR TEMA ELBOW WAS IMPLANTED (SUBJECT OF THIS REPORT). ·ON (B)(6) 2022, THE SURGEON PERFORMED A CONVERSION SURGERY TO LINK THE COMPONENTS (NO EXPLANT). THIS EVENT IS REGISTERED AS LIMACORPORATE COMPLAINT (B)(4). EVENT HAPPENED IN UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2509104 ELBOW ULNAR STEM ULNAR STEM U5 JDB LIMACORPORATE S.P.A. 1575.14.010 1715495
    820576 ELBOW ULNAR STEM ULNAR STEM U5 JDB LIMACORPORATE S.P.A. 1575.14.010 1715495

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention