BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR GLENOID PEG TT SMALL-R #L

    MDR report key: 12710257 · Received October 28, 2021

    Report

    Report Number
    3008021110-2021-00081
    Event Type
    Injury
    Date Received
    October 28, 2021
    Date of Event
    October 14, 2021
    Report Date
    January 31, 2022
    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 STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS FOUND. THEREFORE, ALL THE PRODUCTS WITH THESE LOT #S HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. EXPLANTS ANALYSIS: THE ITEMS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. X-RAYS ANALYSIS LIMACORPORATE RECEIVED ONE X-RAY REFERRING TO PRE-OPERATIVE REVISION SURGERY. THE X-RAY RECEIVED - EXACT DATE NOT KNOWN - HAS BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "THE RADIOGRAPHS SHOW ADVANCED LYTIC BONE RESORPTION BOTH ON THE HUMERAL SIDE AND ON THE GLENOID SIDE. GIVEN THE HISTORY OF SUSPICION FOR INFECTION THIS IS THE REASON FOR THE LOOSENING OF THE IMPLANT. THERE IS NO INDICATION FOR IMPLANT RELATED FAILURE HERE". CONSIDERING THAT: CHECK OF THE STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON THE TOTAL NUMBER OF COMPONENTS MANUFACTURED WITH THE INVOLVED LOT #S; ACCORDING TO THE MEDICAL CONSULTANT "THE RADIOGRAPHS SHOW ADVANCED LYTIC BONE RESORPTION BOTH ON THE HUMERAL SIDE AND ON THE GLENOID SIDE. GIVEN THE HISTORY OF SUSPICION FOR INFECTION THIS IS THE REASON FOR THE LOOSENING OF THE IMPLANT"; WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR REVERSE PROSTHESIS DUE TO INFECTION IS 0.06%. 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.

    Additional Manufacturer Narrative · 0

    BY CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS FOUND ON THE OVERALL COMPONENTS PLACED ON THE MARKET WITH THE SAME LOT #S. WE WILL SUBMIT A FINAL REPORT ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2021, DUE IMPLANT LOOSENING. THE REASON FOR THE LOOSENING IS A SUSPECTED INFECTION. THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR GLENOID PEG TT SMALL-R #L (PRODUCT CODE 1375.14.653, LOT #2007769 - STER. 2000264). SMR GLENOID BASEPLATE SMALL-R (PRODUCT CODE 1375.15.605, LOT #2005910 - STER. 2000220). BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT #2006407 - STER. 2000204). CORTICAL BONE SCREW D.4,5 L.38MM (PRODUCT CODE 8431.15.038, LOT #1702123 - STER. 1800056). SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE 1352.15.005, LOT #2010263 - STER. 2000223). SMR REVERSE LINER STANDARD (PRODUCT CODE 1360.50.010, LOT #18AT2MR - STER. 1900099). PRODUCT NOT SOLD IN THE US: SMR GLENOSPHERE Ø 36MM (PRODUCT CODE 1374.09.111, LOT #1916170 - STER. 1900367). SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT #2005409 - STER. 2000172). SMR CEMENTLESS FINNED STEM Ø15 (PRODUCT CODE 1304.15.150, LOT #0903305 - STER. 0900244). A CEMENT SPACER WAS USED TO OCCUPY THE JOINT UNTIL NEXT STAGE. IT WAS REPORTED THAT PATIENT HAS SIGNIFICANT GLENOID DEFECT AND A CUSTOM-MADE GLENOID MIGHT BE CHOSEN FOR NEXT STAGE. ACCORDING TO THE COMPLAINT SOURCE, SWABS WERE TAKEN THROUGHOUT THE PROCEDURE, HOWEVER THE RESULTS WERE NOT AVAILABLE. HISTORY OF SHOULDER SURGERIES: ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2010. FIRST REVISION SURGERY WAS PERFORMED ON (B)(6) 2020, DUE TO CUFF FAILURE: IT WAS REGISTERED AS COMPLAINT #(B)(4) AND REPORTED TO THE FDA BY MIR #3008021110-2020-00116 SECOND REVISION SURGERY WAS PERFORMED ON OCTOBER 14TH, 2021, DUE TO IMPLANT LOOSENING (HEREBY REPORTED). PATIENT IS A FEMALE, 77 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2021, DUE IMPLANT LOOSENING. THE REASON FOR THE LOOSENING IS A SUSPECTED INFECTION. THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR GLENOID PEG TT SMALL-R #L (PRODUCT CODE 1375.14.653, LOT #2007769 - STER. 2000264). SMR GLENOID BASEPLATE SMALL-R (PRODUCT CODE 1375.15.605, LOT #2005910 - STER 2000220). BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT #2006407 - STER. 2000204). CORTICAL BONE SCREW D.4,5 L.38MM (PRODUCT CODE 8431.15.038, LOT #1702123 - STER 1800056). SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE 1352.15.005, LOT #2010263 - STER. 2000223). SMR REVERSE LINER STANDARD (PRODUCT CODE 1360.50.010, LOT #18AT2MR - STER. 1900099). - PRODUCT NOT SOLD IN THE US. SMR GLENOSPHERE Ø 36MM (PRODUCT CODE 1374.09.111, LOT #1916170 - STER. 1900367). SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT #2005409 - STER. 2000172). SMR CEMENTLESS FINNED STEM Ø15 (PRODUCT CODE 1304.15.150, LOT #0903305 - STER 0900244). A CEMENT SPACER WAS USED TO OCCUPY THE JOINT UNTIL NEXT STAGE. IT WAS REPORTED THAT PATIENT HAS SIGNIFICANT GLENOID DEFECT AND A CUSTOM-MADE GLENOID MIGHT BE CHOSEN FOR NEXT STAGE. ACCORDING TO THE COMPLAINT SOURCE, SWABS WERE TAKEN THROUGHOUT THE PROCEDURE, HOWEVER THE RESULTS ARE NOT KNOWN YET. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2020. IT WAS DUE TO CUFF FAILURE AND REPORTED TO THE FDA WITH MIR # 3008021110-2020-00116 ((B)(4)). PATIENT IS A FEMALE, (B)(6). EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1612002 SMR GLENOID PEG TT SMALL-R #L SMR TT METAL BACK PEG (TI6AL4V) - S-R LONG KWS LIMACORPORATE S.P.A. 1375.14.653 2007769

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other