BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CTA HUMERAL HEADS (COCRMO) DIA.54MM

    MDR report key: 10188935 · Received June 24, 2020

    Report

    Report Number
    3008021110-2020-00045
    Event Type
    Injury
    Date Received
    June 24, 2020
    Date of Event
    June 8, 2020
    Report Date
    March 19, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    HSD
    PMA / PMN Number
    K110847
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BY THE CHECK OF THE STERILIZATION CHARTS OF THE COMPONENTS INVOLVED, NO PRE-EXISITING ANOMALY WAS DETECTED, THUS WE CAN STATE THAT THESE COMPONENTS HAD BEEN REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. MOREOVER, WE ARE NOT AWARE OF OTHER CASES OF INFECTION INVOLVING THE SAME STERILIZATION LOT NUMBERS. XRAYS DATED (B)(6) 2020 WERE PROVIDED BY THE COMPLAINT SOURCE. THE XRAYS WERE ANALYZED BY OUR MEDICAL CONSULTANT, WHO COMMENTED: "WITH THE INFORMATION AVAILABLE THERE IS NOT MUCH TO SAY. INFECTION IS A RECOGNISED AND ACCEPTED COMPLICATION OF ALL SURGERY. IT IS PARTICULARLY SERIOUS IN ARTHROPLASTY BECAUSE OF THE DIFFICULTY IN ERADICATING THE INFECTION WITH A RETAINED IMPLANT, SO IT CAN REASONABLY BE SAID THE SURGEON DID THE RIGHT THING TO REMOVE ALL OF THE PROSTHESIS AND IMPLANT AN ANTIBIOTIC SPACER. THAT SAID IT WAS JUST OVER 6 WEEKS FROM THE TIME OF THE INDEX PROCEDURE. IN THE LOWER LIMB IT IS RECOMMENDED IF THE INFECTION OCCURS WITHIN 6 WEEKS "DAIR" (DEBRIDEMENT AND IMPLANT RETENTION) CAN BE CONSIDERED. THIS DOES NOT USUALLY APPLY TO THE SHOULDER BUT THERE MAY BE CIRCUMSTANCES WHERE IT MIGHT BE CONSIDERED." IN CONCLUSION, WITH THE VERY FEW AVAILABLE INFORMATION, WE CANNOT GO BACK WITH CERTAINTY TO THE ROOT CAUSE OF THIS INFECTION. HOWEVER, BASED ON THE ABSENCE OF ANOMALIES DETECTED BY THE CHECK OF THE DHRS, WE CAN STATE THAT THE INVOLVED COMPONENTS HAD BEEN REGULARLY STERILIZED BEFORE REACHING THE MARKET, THUS, THIS EVENT CANNOT BE CLASSIFIED AS PRODUCT RELATED. PMS DATA: ACCORDING TO OUR PMS DATA, WE CAN ESTIMATE A REVISION RATE OF SMR HEMI PROSTHESIS DUE TO INFECTION OF AROUND 0.06%. NO CORRECTIVE ACTION IS NEEDED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT FURTHER SIMILAR ISSUES. NOTE: THIS IS A FINAL MDR.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY DUE TO INFECTION PERFORMED ON (B)(6) 2020. THIS PATIENT'S SURGICAL HISTORY CAN BE SUMMARIZED AS FOLLOWS: - PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2015. SMR REVERSE WAS IMPLANTED. - FIRST REVISION SURGERY WAS PERFORMED ON (B)(6) 2020. THE CAUSE FOR THIS REVISION WAS CUFF FAILURE. EVENT ASSOCIATED WITH MFR # 3008021110-2020-00047 (LIMACORPORATE COMPLAINT #(B)(4)). - SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2020. THE CAUSE FOR THIS REVISION WAS CONTINUOS DISLOCATION. EVENT ASSOCIATED WITH MFR # 3008021110-2020-00030 (LIMACORPORATE COMPLAINT# (B)(4)). DURING THIS REVISION A HEMI PROSTHESIS WAS IMPLANTED. - THIRD REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 DUE TO INFECTION (OBJECT OF THIS REPORT: LIMACORPORATE COMPLAINT #(B)(4)). ACCORDING TO THE INFORMATION RECEIVED, THE FOLLOWING COMPONENTS WERE EXPLANTED DURING THE LAST REVISION SURGERY (ON (B)(6) 2020): - SMR CEMENTLESS FINNED STEM CODE 1304.15.240 LOT 1206228, STERILIZATION (B)(6)(IMPLANTED DURING PRIMARY SURGERY) - SMR REVERSE HUMERAL BODY CODE 1352.15.010 LOT 1918668, STERILIZATION (B)(6) (IMPLANTED DURING REVISION SURGERY ON (B)(6) 2020) - SMR CTA HEADS ADAPTOR Ø36 MM CODE 1352.15.200 LOT 1313952, STERILIZATION (B)(6) (IMPLANTED DURING REVISION SURGERY ON (B)(6) 2020) - SMR CTA HEAD CODE 1323.09.540 LOT 1905201, STERILIZATION (B)(6) (IMPLANTED DURING REVISION SURGERY ON (B)(6) 2020) A SPACER WAS THEN IMPLANTED. PATIENT DATA: MALE, 60 YEARS OLD EVENT HAPPENED IN THE UNITED STATES.

    Additional Manufacturer Narrative · 1

    WE WILL PROVIDE A FINAL MDR AS SOON AS THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    SHOULDER REVISION SURGERY DUE TO INFECTION PERFORMED ON (B)(6) 2020. THIS PATIENT'S SURGICAL HISTORY CAN BE SUMMARIZED AS FOLLOWS: PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2015. SMR REVERSE WAS IMPLANTED; FIRST REVISION SURGERY WAS PERFORMED ON (B)(6) 2020. THE CAUSE FOR THIS REVISION WAS CUFF FAILURE. EVENT ASSOCIATED WITH COMPLAINT # 3008021110-2020-00047 (LIMACORPORATE COMPLAINT #(B)(4)); - SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2020. THE CAUSE FOR THIS REVISION WAS CONTINOUS DISLOCATION. EVENT ASSOCIATED WITH COMPLAINT # 3008021110-2020-00030 (LIMACORPORATE COMPLAINT# (B)(4)). DURING THIS REVISION A HEMI PROSTHESIS WAS IMPLANTED; - THIRD REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 DUE TO INFECTION (OBJECT OF THIS REPORT: LIMACORPORATE COMPLAINT #(B)(4)). ACCORDING TO THE INFORMATION RECEIVED, THE FOLLOWING COMPONENTS WERE EXPLANTED DURING THE LAST REVISION SURGERY (ON (B)(6) 2020): - SMR CEMENTLESS FINNED STEM CODE 130415240 LOT 1206228 STER. 1200375 (IMPLANTED DURING PRIMARY SURGERY) - SMR REVERSE HUMERAL BODY CODE 135215010 LOT 1918668 STER. 1900408 (IMPLANTED DURING REVISION SURGERY ON (B)(6) 2020) - SMR CTA HEADS ADAPTOR 36 MM CODE 135215200 LOT 1313952 STER.1900384 (IMPLANTED DURING REVISION SURGERY ON (B)(6) 2020) - SMR CTA HEAD CODE 132309540 LOT 1905201 STER.1900165 (IMPLANTED DURING REVISION SURGERY ON (B)(6) 2020) A SPACER WAS THEN IMPLANTED. A SWAB ANALYSIS WAS PERFORMED, BUT THE RESULTS WERE NOT PROVIDED TO LIMACORPORATE. PATIENT DATA: MALE, (B)(6) YEARS OLD EVENT HAPPENED IN THE USA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655401 CTA HUMERAL HEADS (COCRMO) DIA.54MM CTA HUMERAL HEADS (COCRMO) DIA.54MM HSD LIMACORPORATE S.P.A. 1323.09.540 1905201

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention