BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR REVERSE HUMERAL BODY SHORT

    MDR report key: 9021271 · Received September 13, 2019

    Report

    Report Number
    3008021110-2019-00106
    Event Type
    Injury
    Date Received
    September 13, 2019
    Date of Event
    August 27, 2019
    Report Date
    September 13, 2019
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    PMA / PMN Number
    K110598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECK OF THE DHR: BY CHECKING THE MANUFACTURING CHART OF THE INVOLVED LOT#/STER., NO ANOMALY WAS FOUND ON THE COMPONENTS MANUFACTURED AND STERILIZED WITH THESE LOT#S. THEREFORE, WE CAN STATE THAT ALL THE COMPONENTS HAVE BEEN REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE STER. LOT#S. EXPLANTS ANALYSIS: EXPLANTS WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE. XRAYS ANALYSIS: XRAYS WERE NOT AVAILABLE TO BE PROVIDED TO LIMACORPORATE. CONCLUSION: VERY FEW INFORMATION AVAILABLE ON THIS CASE: EVEN IF REQUESTED TO THE COMPLAINT SOURCE, INFORMATION SUCH AS PATIENT'S CLINICAL CONDITIONS, X-RAYS AND GERM RESPONSIBLE WAS NEVER PROVIDED TO US. THUS, NO DEFINITIVE CONCLUSION ON THE CAUSE FOR THE INFECTION CAN BE DRAWN. HOWEVER, BASED ON THE CHECK OF THE STERILIZATION CHARTS (NO DEVIATION DETECTED), THIS EVENT CANNOT BE CLASSIFIED AS PRODUCT RELATED. PMS DATA: ACCORDING TO OUR PMS DATA, REVISION RATE OF SMR REVERSE DUE TO INFECTION IS (B)(4). NO CORRECTIVE ACTIONS PLANNED FOR THIS CASE. LIMACORPORATE WILL KEEP MONITORED THE MARKET.

    Description of Event or Problem · 0

    FIRST STAGE REVISION SURGERY DUE TO INFECTION PERFORMED ON THE (B)(6) 2019. PREVIOUS SURGERY WAS PERFORMED ON THE (B)(6) 2019. ACCORDING TO THE AVAILABLE INFORMATION, DURING CURRENT SURGERY, THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR REVERSE HUMERAL BODY SHORT, CODE 1352.15.005, LOT# 1900187, STER.1900051. SMR REVERSE HP LINER MEDIUM, CODE 1362.09.015, CODE LOT# 1816775, STER.1800383. SMR CONNECTOR SMALL STD, CODE 1374.15.310, LOT# 1904625, STER.1900108. SMR REVERSE HP GLENOSPH. 44 MM, CODE 1374.50.440, LOT# 1903215, STER.1900089. AFTER REMOVAL OF THE COMPONENTS, ANTIBIOTIC CEMENT SPACER WAS INSERTED. NO OTHER INFORMATION WAS RECEIVED FROM THE COMPLAINT SOURCE. EVENT HAPPENED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    CHECK OF THE DHR: BY CHECKING THE MANUFACTURING CHART OF THE INVOLVED LOT#/STER., NO ANOMALY WAS FOUND ON THE WHOLE COMPONENTS MANUFACTURED AND STERILIZED WITH THESE LOT#S. THEREFORE, WE CAN STATE THAT ALL THE COMPONENTS HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT#S. XRAYS ANALYSIS: WE REQUESTED XRAY IMAGES TO INVESTIGATE THIS CASE BUT THEY WERE NOT AVAILABLE. WE ARE WAITING FOR FURTHER INFO REGARDING THE OTHER COMPONENTS EXPLANTED. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    FIRST STAGE REVISION DUE TO INFECTION PERFORMED ON THE (B)(6) 2019. PREVIOUS SURGERY WAS PERFORMED ON THE (B)(6) 2019. DURING CURRENT SURGERY, THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR REVERSE HUMERAL BODY SHORT, CODE 1352.15.005, LOT# 1900187, STER.1900051; SMR CONNECTOR SMALL STD, CODE 1374.15.310, LOT# 1904625, STER.1900108; SMR REVERSE HP LINER MEDIUM, NOT MARKED IN USA; SMR REVERSE HP GLENOSPH. 44 MM, NOT MARKED IN USA. IT WAS REPORTED THAT ALL THE IMPLANTS WERE EXPLANTED BUT ONLY THE LISTED ONES WERE REPORTED TO US. AFTER REMOVAL, ANTIBIOTIC CEMENT SPECER WAS INSERTED. NO OTHER INFO WERE RECEIVED BY THE COMPLAINT SOURCE. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823432 SMR REVERSE HUMERAL BODY SHORT SMR REVERSE HUMERAL BODY SHORT KWS LIMACORPORATE S.P.A. 1352.15.005 1900187

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention