BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMERAL STEM #H6 LEFT

    MDR report key: 16484032 · Received March 6, 2023

    Report

    Report Number
    3008021110-2023-00016
    Event Type
    Injury
    Date Received
    March 6, 2023
    Date of Event
    July 27, 2022
    Report Date
    January 11, 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

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT#: 1814674, NO PRE-EXISTING ANOMALIES WERE FOUND ON THE COMPONENTS WITH THAT LOT#. WE SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #1814674 NO PRE-EXISTING ANOMALIES WERE FOUND ON THE COMPONENTS WITH THAT LOT #. THE ITEMS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE 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; ·CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH THE INVOLVED LOT #. WE CAN SUPPOSE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF TEMA PROSTHESIS DUE TO LOOSENING IS 0.12%. 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 ISSUES. NOTE: THIS IS THE FINAL MDR.

    Description of Event or Problem · 0

    ELBOW REVISION SURGERY OF A TEMA IMPLANT PERFORMED ON (B)(6) 2022, DUE TO LOOSENING OF THE HUMERAL STEM #H6 LEFT (PRODUCT CODE: 1504.14.060, LOT#: 1814674 - STER. 1900298). THE FOLLOWING COMPONENTS GOT EXPLANTED: HUMERAL STEM #H6 LEFT (PRODUCT CODE: 1504.14.060, LOT#: 1814674 - STER. 1900298). HUMERAL BODY SMALL LEFT+SCREW (PRODUCT CODE: 1550.15.010, LOT#:1714100 - STER. 1900184). THE STEM WAS EXCHANGED TO ONE SIZE #10 AND A NEW HUMERAL BODY WAS PLACED IN. PATIENT'S HISTORY OF REVISION SURGERIES IS THE FOLLOWING: PRIMARY IMPLANT TOOK PLACE ON (B)(6) 2020; FIRST REVISION SURGERY PERFORMED ON (B)(6) 2021, DUE TO HUMERAL LOOSENING (EVENT REGISTERED AS COMPLAINT#: (B)(4) AND REPORTED TO THE FDA BY MFR 3008021110-2023-00015); SECOND REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO HUMERAL LOOSENING (HEREBY REPORTED); THIRD REVISION SURGERY PERFORMED ON (B)(6) 2023, DUE TO HUMERAL LOOSENING (EVENT REGISTERED AS COMPLAINT#: (B)(4) AND REPORTED TO THE FDA BY MFR 3008021110-2023-00019). PATIENT IS A FEMALE, 37 YEARS OLD. EVENT HAPPENED IN THE US.

    Description of Event or Problem · 0

    ELBOW REVISION SURGERY OF A TEMA IMPLANT PERFORMED ON (B)(6) 2022, DUE TO LOOSENING OF THE HUMERAL STEM #H6 LEFT (PRODUCT CODE 1504.14.060, LOT #1814674 - STER. (B)(4)). THE FOLLOWING COMPONENTS GOT EXPLANTED: - HUMERAL STEM #H6 LEFT (PRODUCT CODE 1504.14.060, LOT #1814674 - STER. (B)(4)) - HUMERAL BODY SMALL LEFT+SCREW (PRODUCT CODE 1550.15.010, LOT #1714100 - STER. (B)(4)) THE STEM WAS EXCHANGED TO ONE SIZE #10 AND A NEW HUMERAL BODY WAS PLACED IN. PATIENT IS A FEMALE, 37 YEARS OLD. EVENT HAPPENED IN THE US. PATIENT MEDICAL HISTORY 12/08/2020 - INITIAL ELBOW SURGERY PERFORMED. 29/09/2021 -REVISION SURGERY FOR REASON IS HUMERAL STEM LOOSENING. THIS EVENT WAS REGISTERED AS LIMACORPORATE COMPLAINT 20220039 AND REPORTED TO FDA AS MFR #3008021110-2023-00015. 27/07/2022 REVISION SURGERY FOR LOOSENING OF THE HUMERAL STEM. (OBJECT OF THIS REPORT) 20/01/2023 REVISION SURGERY DUE TO LOOSENING OF THE HUMERAL STEM. THIS EVENT WAS REGISTERED AS LIMACORPORATE COMPLAINT 20220054 AND REPORTED TO FDA AS MFR #3008021110-2023-00019. 20/01/2023 DURING REVISION SURGERY THE INSTRUMENT WAS BROKEN. THIS EVENT WAS REGISTERED AS LIMACORPORATE COMPLAINT (B)(4) AND REPORTED TO FDA AS MFR #3008021110-2023-00014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1573834 HUMERAL STEM #H6 LEFT HUMERAL STEM #H6 LEFT JDB LIMACORPORATE S.P.A 1504.14.060 1814674

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Other| R