BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 18283678 · Received December 7, 2023

    Report

    Report Number
    3008021110-2023-00134
    Event Type
    Injury
    Date Received
    December 7, 2023
    Date of Event
    October 11, 2023
    Report Date
    September 15, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    MBF
    UDI-DI
    08033390087834
    PMA / PMN Number
    K163397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DHRS OF THE INVOLVED PRODUCT CODES AND LOT NUMBERS HAVE BEEN CHECKED, WITHOUT FINDING ANY ANOMALY. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION THE DHRS OF THE INVOLVED PRODUCT CODES AND LOT NUMBERS HAVE BEEN CHECKED, WITHOUT FINDING ANY PRE-EXISTING ANOMALY, THAT COULD HAVE CONTRIBUTED TO THE EVENT. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT NUMBERS. WE DID NOT RECEIVE ANY RADIOGRAPHY OR EXPLANTED COMPONENTS. HOWEVER, WE RECEIVED FROM THE COMPLAINT SOURCE THE FOLLOWING INFORMATION: "THE PATIENT HAD A REVISION OF THE SMR COCR GLENOSPHERE FOR A TITANIUM ONE, DUE TO BEING POSITIVE FOR A NICKEL ALLERGY ON 11TH OCTOBER 2023. THE GLENOSPHERE WAS SUCCESSFULLY REPLACED, AS WELL AS THE HUMERAL BODY AND LINER THAT WAS PREVIOUSLY IMPLANTED DURING A SURGERY THAT OCCURRED ON 5TH DECEMBER 2022. THERE WAS NO REASON PROVIDED FOR REPLACING THESE COMPONENTS NOR WAS THERE ANY ISSUE REPORTED BY THE SURGEON. THE HUMERAL STEM WAS NOTED TO BE WELL FIXED AND RETAINED AS WAS THE GLENOID BASEPLATE. ADDITIONALLY, THE AGENT CONFIRMED ON 21ST NOVEMBER 2023 THAT A NEW BASEPLATE (CODE 1379.15.160, LOT NUMBER 2201696) WAS NOT IMPLANTED. THE SURGEON SIMPLY USED THE SAFETY SCREW FROM THE BASEPLATE BOX TO SECURE THE NEW GLENOSPHERE. POSTOPERATIVELY, THE PATIENT EXPRESSED FEELING MUCH BETTER THAN BEFORE, AND NO ISSUES WERE REPORTED." THEREFORE, CONSIDERING THAT: NO PRE-EXISTING ANOMALY WAS DISCOVERED BY CHECKING THE MANUFACTURING CHARTS OF THE COMPONENTS INVOLVED IN THIS EVENT THE REASON FOR THE REVISION WAS MAINLY RELATED TO THE NICKEL-METAL ALLERGY OF THE PATIENT. WE CAN CONCLUDE THAT THE EVENT IS NOT PRODUCT RELATED. PMS DATA ACCORDING TO THE AVAILABLE PMS DATA, THE REVISION RATE OF SMR GLENOSPHERES BELONGING TO THE FAMILY PRODUCT CODES 1374.09.XXX, 1376.09.XXX, 1374.15.XXX, 1376.15.XXX DUE TO ALLERGY IS LOWER THAN 0.01%. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS ARE REQUIRED FOR THIS SPECIFIC CASE. THE MANUFACTURER WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUES. NOTE: THIS IS A FINAL MDR

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED ON 11TH OCTOBER 2023 DUE TO PAIN AND NICKEL-METAL ALLERGY. THE PATIENT'S SHOULDER PROSTHESIS HAS BEEN REVISED WITH THE COMPASSIONATE USE DEVICE CMD 23-1224. THE COMPONENTS INVOLVED IN THE REVISION SURGERY WERE THE FOLLOWING: - SMR REVERSE HUMERAL BODY (PRODUCT CODE 1352.15.010, LOT 2214887, STERILIZATION NUMBER 2200196) - SMR REVERSE LINER STANDARD (PRODUCT CODE 1360.50.810, LOT 20AT4UX, STERILIZATION NUMBER 2100137) - SMR ECCENT. GLENOSPHERE Ø 36MM (PRODUCT CODE 1376.09.031, LOT 2217722, STERILIZATION NUMBER 2200224) - TT HYBRID REVERSE BASEPLATE #S (PRODUCT CODE 1379.15.160, LOT 2209111, STERILIZATION NUMBER 2200136) THE PREVIOUS SURGERY WAS PERFORMED ON DECEMBER 5TH 2022. EVENT HAPPENED IN UNITED STATES.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED ON (B)(6) 2023 DUE TO PAIN AND NICKEL-METAL ALLERGY. THE PATIENT'S SHOULDER PROSTHESIS HAS BEEN REVISED WITH THE COMPASSIONATE USE DEVICE CMD 23-1224 (TITANIUM GLENOSPHERE). THE COMPONENTS REMOVED IN THE REVISION SURGERY WERE THE FOLLOWING: SMR REVERSE HUMERAL BODY (PART CODE 1352.15.010, LOT NUMBER 2214887, STERILIZATION (B)(4). SMR REVERSE LINER STANDARD (PART CODE 1360.50.810, LOT NUMBER 20AT4UX, STERILIZATION (B)(4). SMR ECCENT. GLENOSPHERE Ø 36MM (PART CODE 1376.09.031, LOT NUMBER 2217722, STERILIZATION (B)(4). THERE COMPONENTS WERE REPLACED BY THE FOLLOWING NEW DEVICES: SMR REVERSE HUMERAL BODY (PART CODE 1352.15.010, LOT NUMBER 2319433, STERILIZATION (B)(4). SMR REVERSE LINER STANDARD (PART CODE 1360.50.810, LOT NUMBER 23AT0VS, STERILIZATION (B)(4). SMR ECC. GLENOSPHERE Ø 36MM (PART CODE 1376.15.031, LOT NUMBER 2310423, STERILIZATION (B)(4). THIS COMPONENT WAS MADE AVAILABLE AS COMPASSIONATE USE DEVICE. THE PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2022. THIS WAS ANOTHER REVISION SURGERY DUE TO CUFF FAILURE. THE PATIENT IS A FEMALE, DATE OF BIRTH (B)(6) 1960. EVENT HAPPENED IN UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1127660 SMR SHOULDER ECCENTRICAL GLENOSPHERE DIA. 36 MM MBF LIMACORPORATE S.P.A. 1376.09.031 2217722 08033390087834

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention