BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CONNECTOR SMALL R

    MDR report key: 10800427 · Received November 6, 2020

    Report

    Report Number
    3008021110-2020-00097
    Event Type
    Injury
    Date Received
    November 6, 2020
    Date of Event
    October 28, 2020
    Report Date
    May 12, 2021
    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

    BY CHECKING THE STERILIZATION CHARTS OF THE INVOLVED PRODUCTS, NO PRE-EXISTING ANOMALIES WERE FOUND, THUS WE CAN STATE THAT ALL THE COMPONENTS HAD BEEN REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. EXPLANTS WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. WE ONLY RECEIVED A TOTAL OF TWO PICTURES OF THE EXPLANTED COMPONENTS. NO ADDITIONAL DETAILS WERE AVAILABLE ON THE POST-OPERATIVE ISSUE, SPECIFICALLY THE FOLLOWING INFORMATION WAS REQUESTED TO THE COMPLAINT SOURCE, BUT IT WAS NOT AVAILABLE: · PRE-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY; · CLINICAL DATA FOR THE PATIENT; · GERM RESPONSIBLE FOR THE INFECTION. BASED ON THE VERY FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, STATING THAT THE CHECK OF THE STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS, WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR REVERSE IMPLANTS DUE TO INFECTION IS (B)(4). NO CORRECTIVE ACTIONS 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 OF A SMR REVERSE PROSTHESIS PERFORMED ON (B)(6), 2020 DUE TO INFECTION. ALTHOUGH THE JOINT WAS STABLE, THE PATIENT DEVELOPED A SINUS INDICATING INFECTION. ACCORDING TO THE COMPLAINT SOURCE, THERE APPEARED TO BE OOZING AND SUSPECT TISSUE THAT ON APPEARANCE WOULD INDICATE POSITIVE SIGNS OF INFECTION. IT WAS REPORTED THAT SAMPLES WERE TAKEN FOR PATHOLOGY. THE FOLLOWING COMPONENTS WERE EXPLANTED: · SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT# 2012929 - STER. 2000263). · SMR REVERSE HUMERAL BODY (PRODUCT CODE 1352.20.010, LOT# 2005937 - STER. 2000167) - PRODUCT NOT MARKETED IN THE US. · SMR REVERSE HP LATERALIZING LINER MEDIUM (PRODUCT CODE 1365.09.115, LOT# 1901658 - STER. 1900092) - PRODUCT NOT MARKETED IN THE US. · SMR REVERSE HP GLENOSPHERE 40 MM (PRODUCT CODE 1374.50.400, LOT# 1918761 - STER. 1900395) - PRODUCT NOT MARKETED IN THE US. NEW COMPONENTS WERE IMPLANTED. PREVIOUS REVISION SURGERY TOOK PLACE ON (B)(6), 2020 (COMPLAINT REF. 2020-200 AU - LIMACORPORATE #279_20). PATIENT IS A FEMALE. EVENT HAPPENED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE STERILIZATION CHARTS OF THE INVOLVED PRODUCTS, NO PRE-EXISTING ANOMALIES WERE FOUND, THUS WE CAN STATE THAT ALL THE COMPONENTS HAD BEEN REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. WE WILL SUBMIT THE FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2020 DUE TO INFECTION. ALTHOUGH THE JOINT WAS STABLE, THE PATIENT DEVELOPED A SINUS INDICATING INFECTION. ACCORDING TO THE COMPLAINT SOURCE, THERE APPEARED TO BE OOZING AND SUSPECT TISSUE THAT ON APPEARANCE WOULD INDICATE POSITIVE SIGNS OF INFECTION. IT WAS REPORTED THAT SAMPLES WERE TAKEN FOR PATHOLOGY. THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT# 2012929 - STER. 2000263). SMR REVERSE HUMERAL BODY (PRODUCT CODE 1352.20.010, LOT# 2005937 - STER. 2000167) - PRODUCT NOT MARKETED IN THE US. SMR REVERSE HP LATERALIZING LINER MEDIUM (PRODUCT CODE 1365.09.115, LOT# 1901658 - STER. 1900092) - PRODUCT NOT MARKETED IN THE US. SMR REVERSE HP GLENOSPHERE 40 MM (PRODUCT CODE 1374.50.400, LOT# 1918761 - STER. 1900395) - PRODUCT NOT MARKETED IN THE US. NEW COMPONENTS WERE IMPLANTED. PREVIOUS REVISION SURGERY TOOK PLACE ON (B)(6) 2020 (COMPLAINT REF. # (B)(4)). PATIENT IS A FEMALE. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1263455 SMR CONNECTOR SMALL R CONNECTOR WITH SCREW SMALL-R KWS LIMACORPORATE S.P.A. 1374.15.305 2012929

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention