BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR GLENOID BASEPLATE STANDARD

    MDR report key: 12369965 · Received August 26, 2021

    Report

    Report Number
    3008021110-2021-00061
    Event Type
    Injury
    Date Received
    August 26, 2021
    Date of Event
    July 16, 2021
    Report Date
    December 17, 2021
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    PMA / PMN Number
    K133349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #1819664, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF (B)(4) MANUFACTURED WITH THE SAME LOT #. ACCORDING TO OUR RECORDS, AT LEAST (B)(4) BASEPLATES WITH LOT #1819664 AND STER. 1900102 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. EXPLANTED COMPONENTS WERE NOT AVAILABLE TO BE RETURNED TO HQ FOR FURTHER ANALYSIS. X-RAYS ANALYSIS: LIMACORPORATE RECEIVED A TOTAL OF TWO X-RAYS REFERRING TO PRE-OP REVISION SURGERY. THE X-RAYS RECEIVED - DATED (B)(6) 2020 AND (B)(6) 2021 - HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "THE REASON FOR REVISION IS INFECTION, WHICH IS NOT RELATED TO THE IMPLANT. THE IMPLANTATION ITSELF LOOKS FINE, NO PROBLEMS HERE. IN SUMMARY I DON'T SEE IMPLANT-RELATED ISSUES HERE, THIS IS A FATEFUL COURSE OF EVENTS". CONSIDERING THAT: · CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE TOTAL NUMBER OF COMPONENTS MANUFACTURED WITH LOT #1819664; · ACCORDING TO THE MEDICAL CONSULTANT, THE REASON OF THE LAST REVISION SURGERY IS INFECTION; WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, THE REVISION RATE OF GLENOID BASEPLATES - BELONGING TO THE FAMILY CODES 1375.15.XXX - DUE TO LOOSENING IS (B)(4). BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, 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 PERFORMED ON (B)(6), 2021, DUE TO LOOSENING OF THE SMR GLENOID BASEPLATE STANDARD (PRODUCT CODE 1375.15.610, LOT #1819664 - STER. 1900102). DURING THE REVISION, THE FOLLOWING COMPONENTS WERE EXPLANTED AND REPLACED: - SMR GLENOID BASEPLATE STANDARD CODE 1375.15.610, LOT 1819664 STER 1900102. - SMR GLENOID PEG TT S/STD/L #S CODE 1375.14.661, LOT 1806160 STER 1800189. - 2X BONE SCREW Ø6,5 H.20MM CODE 8420.15.010, LOT 1903692 STER 1900291. - SMR REVERSE HUMERAL BODY CODE 1352.20.010, LOT 1910648 STER 1900292 - PRODUCT NOT MARKETED IN THE US. - SMR REVERSE HP LINER LONG CODE 1362.09.020, LOT 1908434 STER 1900265 - PRODUCT NOT MARKETED IN THE US. - SMR CONNECTOR SMALL STD CODE 1374.15.310, LOT 1903692 STER 1900102. - SMR REVERSE HP GLENOSPH. 44 MM CODE 1374.50.440, LOT 1915854 STER 1900346 - PRODUCT NOT MARKETED IN THE US. THE PATIENT HAD A HISTORY OF INFECTION IN THE AFFECTED SHOULDER, WHICH WAS TREATED BEFORE THE LAST SURGERY. HE UNDERWENT SEVERAL REVISION SURGERIES, AS FOLLOWS: - PRIMARY SURGERY PERFORMED ON (B)(6) 2016 - 1ST REVISION SURGERY PERFORMED ON THE (B)(6) 2018 (COMPLAINT #(B)(4), DUE TO CUFF FAILURE, NOT REPORTED TO THE FDA AS RELATED TO PATIENT'S CONDITION). - 2ND REVISION SURGERY DUE TO INFECTION, PERFORMED IN TWO STAGES ((B)(6) 2018 - COMPLAINT (B)(4), REPORTED TO THE FDA BY MFR #3008021110-2018-00092, AND (B)(6) 2018 - COMPLAINT #(B)(4), REPORTED TO THE FDA BY MFR #3008021110-2018-00118). - 3RD REVISION SURGERY PERFORMED ON THE (B)(6) 2018 (THIS CASE WAS NOT REPORTED TO LIMACORPORATE, ROOT CAUSE OF EVENT IS STILL UNKNOWN). - 4TH REVISION SURGERY DUE TO INFECTION (2 STAGES: (B)(6) AND (B)(6), 2019 - COMPLAINT# (B)(4), REPORTED TO THE FDA BY MFR #3008021110-2019-00101). - 5TH REVISION SURGERY PERFORMED ON THE (B)(6) 2021 (COMPLAINT (B)(4), OBJECT OF THE CURRENT REPORT). PATIENT IS A MALE, 66 YEARS OLD. EVENT OCCURRED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY THE CHECK OF THE DHR, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE 30 METAL BACK GLENOIDS PLACED ON THE MARKET WITH LOT 1819664. THIS IS THE 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 LOOSENING OF THE METAL GLENOID WITH PRODUCT CODE 1375.15.610 AND LOT# 1819664, STER. 1900102. THE REVISION SURGERY TOOK PLACE ON 16TH JULY 2021, WHEN THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR REVERSE HUMERAL BODY CODE 135220010, LOT 1910648 STER 1900292. SMR REVERSE HP LINER LONG CODE 136209020, LOT 1908434 STER 1900265. SMR CONNECTOR SMALL STD CODE 137415310, LOT 1903692 STER 1900102. SMR REVERSE HP GLENOSPH. 44 MM CODE 137450440, LOT 1915854 STER 1900346. SMR GLENOID PEG TT S/STD/L #S CODE 137514661, LOT 1806160 STER 1800189. SMR GLENOID BASEPLATE STANDARD CODE 137515610, LOT 1819664 STER 1900102. 2X BONE SCREW Ø6,5 H.20MM CODE 842015010, LOT 1903692 STER 1900291. THE PATIENT HAD A HISTORY OF INFECTION IN THE AFFECTED SHOULDER, WHICH WAS TREATED BEFORE THE LAST SURGERY. HE UNDERWENT SEVERAL REVISION SURGERIES, AS PER FOLLOWS: PRIMARY SURGERY PERFORMED ON (B)(6) 2016. 1ST REVISION SURGERY PERFORMED ON THE (B)(6) 2018 (COMPLAINT #(B)(4), DUE TO CUFF FAILURE, NOT REPORTED TO FDA AS RELATED TO PATIENT'S CONDITION) . 2ND REVISION SURGERY DUE TO INFECTION, PERFORMED IN TWO STAGES (B)(6) 2018 - COMPLAINT (B)(4). AND (B)(6) 2018 - COMPLAINT #(B)(4). 3RD REVISION SURGERY PERFORMED ON THE (B)(6) 2018 (THIS CASE WAS NOT REPORTED TO LIMACORPORATE, ROOT CAUSE OF EVENT IS STILL UNKNOWN). 4TH REVISION SURGERY DUE TO INFECTION (2 STAGES: (B)(6) 2019, (B)(6) 2019 - COMPLAINT# (B)(4). 5TH REVISION SURGERY PERFORMED ON THE (B)(6) 2021 (COMPLAINT (B)(4), OBJECT OF THE CURRENT REPORT). ACCORDING TO THE INFORMATION RECEIVED, THE ORIGINAL PLAN WAS TO IMPLANT A CUSTOM-MADE GLENOID, BUT SURGEON EVENTUALLY DECIDED TO USE A STANDARD TT METAL BACK GLENOID. PATIENT IS (B)(6)YEARS OLD. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1267921 SMR GLENOID BASEPLATE STANDARD SMR TT METAL BACK BASEPLATE (TI6AL4V) - STANDARD KWS LIMACORPORATE S.P.A. 1375.15.610 1819664

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention