BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CEMENTLESS FINNED STEM 19

    MDR report key: 11115700 · Received January 5, 2021

    Report

    Report Number
    3008021110-2020-00122
    Event Type
    Injury
    Date Received
    January 5, 2021
    Date of Event
    December 29, 2020
    Report Date
    May 20, 2021
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    HSD
    PMA / PMN Number
    K101263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT#, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 60 ITEMS MANUFACTURED WITH THE SAME LOT#. ACCORDING TO OUR RECORDS, ALL 60 CEMENTLESS STEMS WITH LOT# 1202648 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. LIMACORPORATE RECEIVED A TOTAL OF TWO X-RAYS REFERRING TO PRE-OP REVISION SURGERY. THE X-RAYS RECEIVED - DATED (B)(6) 2020- HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "[?]WHILE THERE IS SOME HUMERAL PROXIMAL STEM REMODELLING, IT IS NOT MUCH AND LESS THAN WE OFTEN SEE. THE REMODELLING HAS NOT CONTRIBUTED TO THE FRACTURE OCCURRENCE. REMODELLING IS A FEATURE SEEN VERY COMMONLY. IT IS SO COMMON THAT I THINK IT CAN BE DESCRIBED AS A NORMAL POST PROSTHESIS APPEARANCE. IT IS NON SPECIFIC TO BRAND, CEMENT OR CEMENTLESS. AS MENTIONED IT HASN'T CONTRIBUTED TO THE FRACTURE SO "NO" THE FRACTURE IS NOT FROM ANY COMPLICATION RELATED TO THE IMPLANT". CONSIDERING THAT: PATIENT HAD A FALL; CHECKING THE MANUFACTURING CHARTS, NO ANOMALIES WERE FOUND ON THE TOTAL NUMBER OF COMPONENTS MANUFACTURED WITH LOT# 1202648; ACCORDING TO THE MEDICAL EXPERT, "THE FRACTURE IS NOT FROM ANY COMPLICATION RELATED TO THE IMPLANT"; WE CAN CLASSIFY THE COMPLAINT AS PATIENT-RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR REVERSE PROSTHESIS DUE TO FRACTURE OF THE HUMERUS BONE IS 0,02%. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTION IS 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

    REVISION SURGERY OF A SHOULDER SMR REVERSE PROSTHESIS DUE TO BONE FRACTURE ON THE HUMERAL SIDE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINT SOURCE, PATIENT HAD A FALL AND THIS EVENT WAS IDENTIFIED TO BE THE CAUSE OF THE BONE FRACTURE. PRIMARY SURGERY PERFORMED ON (B)(6) 2013. ACCORDING TO THE INFORMATION REPORTED, THE SMR CEMENTLESS FINNED STEM DIA. 19MM (PRODUCT CODE 1304.15.190, LOT# 1202648 - STER. 1200178) WAS REPLACED WITH A NEW REVISION HUMERAL STEM, A NEW REVERSE BODY PLUS A NEW REVERSE LINER. SURGEON HAPPY WITH THE FINAL STABILITY OF THE PROSTHESIS. NO INFO ABOUT PATIENT ACTIVITY LEVEL. EVENT HAPPENED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    CHECK OF DHR: NO PRE-EXISTING ANOMALIES FOUND ON A TOTAL OF 60 SMR HUMERAL STEM MANUFACTURED WITH LOT# 1202648. NO OTHER COMPLAINTS RECEIVED INVOLVING THE SAME LOT#. WE WILL SEND A FINAL INCIDENT REPORT ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    REVISION SURGERY OF A SMR REVERSE PROSTHESIS DUE TO BONE FRACTURE ON THE HUMERAL SIDE PERFORMED ON (B)(6) 2020. PRIMARY SURGERY PERFORMED ON (B)(6) 2013. ACCORDING TO THE INFO REPORTED, HUMERAL SIDE WAS REPLACED WITH A NEW REVISION HUMERAL STEM, A NEW REVERSE BODY PLUS A NEW REVERSE LINER. NO PROBLEM EXPERIENCED. SURGEON HAPPY WITH THE FINAL STABILITY OF THE PROSTHESIS. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14227 SMR CEMENTLESS FINNED STEM 19 FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.19MM HSD LIMACORPORATE S.P.A. 1304.15.190 1202648

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention