BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR ECCENT. GLENOSPHERE Ø 36MM

    MDR report key: 12086299 · Received June 29, 2021

    Report

    Report Number
    3008021110-2021-00051
    Event Type
    Injury
    Date Received
    June 29, 2021
    Date of Event
    June 22, 2021
    Report Date
    September 18, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    PMA / PMN Number
    K163397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BY THE CHECK OF THE DHR, NEITHER PRE-EXISTING ANOMALY WAS FOUND ON THE (B)(4) GLENOSPHERES WITH CODE 1376.09.031, LOT 2001832 AND STERILIZATION (B)(4), NOR ON THE (B)(4) LINERS WITH CODE 1360.50.820 AND LOT 20AT464 AND STERILIZATION (B)(4). ACCORDING TO OUR RECORDS, AT LEAST (B)(4) GLENOSPHERES MANUFACTURED WITH LOT 2001832 AND STERILIZATION (B)(4) HAVE BEEN IMPLANTED AND AT LEAST (B)(4) LINERS WITH LOT 20AT464 AND STERILIZATION (B)(4) HAVE BEEN IMPLANTED, AND THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THE SAME LOT NUMBERS. THE COMPONENTS REMOVED WERE NOT AVAILABLE TO BE RETURNED FOR INSPECTION AND WE DID NOT RECEIVE ANY RADIOGRAPHY FOR THE CASE. THEREFORE, BASED ON THE FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE EVENT. HOWEVER, CONSIDERING THAT: - NO PRE-EXISTING ANOMALY HAS BEEN DISCOVERED BY CHECKING THE MANUFACTURING CHARTS OF THE LOT NUMBERS 2001832 AND 20AT464. WE HAVE NO EVIDENCE TO CONSIDER THE EVENT AS PRODUCT RELATED. PMS DATA: ACCORDING TO THE RELEVANT PMS DATA, THE REVISION RATE OF SMR REVERSE PROSTHESES DUE TO JOINT DISLOCATION IS (B)(4). 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

    SHOULDER REVISION SURGERY DUE TO DISLOCATION PERFORMED ON THE (B)(6) 2021. THE PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2021. THE FOLLOWING COMPONENTS WERE REMOVED AND REPLACED: - SMR REVERSE LINER +6 MM (PART CODE 1360.50.820, LOT NUMBER 20AT464, STERILIZATION (B)(4)). - SMR CONNECTOR SMALL R (PART CODE 1374.15.305, LOT NUMBER 2102395, STERILIZATION (B)(4)). - SMR ECCENT. GLENOSPHERE Ø 36MM (PART CODE 1376.09.031, LOT NUMBER 2001832, STERILIZATION (B)(4)). ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT WAS DOING GREAT FOR OVER A MONTH, THEN DISLOCATED. A LARGER GLENOSPHERE WAS IMPLANTED. PATIENT DATA: TALL, 225 KG AT THE TIME OF SURGERY, NOT OBESE. EVENT OCCURRED IN THE UNITED STATES.

    Additional Manufacturer Narrative · 1

    BY THE CHECK OF THE DHR, NO PRE-EXISTING ANOMALY WAS FOUND ON THE GLENOSPHERE WITH CODE 1376.09.031 AND LOT 2001832. FIRST AND ONLY COMPLAINT RECEIVED ON THE SAME LOT#. WE WILL SUBMIT THE FINAL MDR AS SOON AS THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    SHOULDER REVISION SURGERY DUE TO DISLOCATION PERFORMED ON THE (B)(6) 2021. THE PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2021. ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT WAS DOING GREAT FOR OVER A MONTHS, THEN DISLOCATED. PATIENT DATA: (B)(6) KG AT THE TIME OF SURGERY. EVENT OCCURRED IN THE USA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985838 SMR ECCENT. GLENOSPHERE Ø 36MM ECCENTRICAL GLENOSPHERE DIA. 36 MM KWS LIMACORPORATE S.P.A. 1376.09.031 2001832

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention