BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR REVERSE FINNED HUMER. BODY

    MDR report key: 17123582 · Received June 14, 2023

    Report

    Report Number
    3008021110-2023-00073
    Event Type
    Injury
    Date Received
    June 14, 2023
    Date of Event
    June 1, 2023
    Report Date
    June 14, 2023
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    PHX
    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 LOTS, NO PRE-EXISTING ANOMALY WAS FOUND ON THE OVERALL NUMBER. THEREFORE, WE CAN ENSURE THAT ALL THE PRODUCTS PLACED ON THE MARKET WITH THESE LOTS HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. WE DID RECEIVE A PRE-OPERATIVE X-RAY WITH THE DATE OF (B)(6) 2023. POST-OPERATIVE X-RAYS WERE REQUESTED TO THE COMPLAINT SOURCE; HOWEVER, THEY WERE NOT AVAILABLE. WE DID RECEIVE PICTURES OF EXPLANTED COMPONENTS AND THESE ALONG WITH THE PREOPERATIVE X-RAY AND INFORMATION IN THIS REPORT WERE SHARED WITH A MEDICAL EXPERT FOR EVALUATION. THE MEDICAL EXPERT'S RESPONSE WAS NO SIGNS FOR IMPLANT RELATED FAILURE. BASED ON THE FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. CONSIDERING THAT: CHECK OF THE STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON COMPONENTS MANUFACTURED WITH THE INVOLVED STERILIZATION LOT #S. THE MEDICAL EXPERT'S EVALUATION RESULTS, THERE WERE NO SIGNS FOR IMPLANT RELATED FAILURE. 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 0.075%. 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 COMBINED INITIAL-FINAL MDR.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR REVERSE PROSTHESIS PERFORMED ON (B)(6)2023, DUE TO INFECTION. IT WAS REPORTED THAT STAGE ONE REVISION OF INFECTED SHOULDER COMPONENTS REMOVED FOR THE INFECTION TO BE TREATED. CEMENT SPACER LEFT IN THE JOINT TO MAINTAIN SOFT-TISSUE BALANCE. REMAINING COMPONENTS WERE EXPLANTED. THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR CEMENTLESS FINNED STEM, COMMERCIAL CODE 1304.15.160 - LOT #2112289 - STER. # 2100225. SMR REVERSE FINNED HUMER. BODY, COMMERCIAL CODE 1352.15.050 - LOT #2105488 - STER. #2100144. SMR REV. HP LAT. LINER MEDIUM, COMMERCIAL CODE 1362.09.115 - LOT #2108026 - STER. #2100218. SMR CONNECTOR SMALL STD, COMMERCIAL CODE 1374.15.310 - LOT #2114594 - STER. #2100240. SMR REVERSE HP GLENOSPH. 44 MM, COMMERCIAL CODE 1374.50.440 - LOT #2108544 - STER. #2100200. SMR UNCEMENT. GLENOID # STD, COMMERCIAL CODE 1375.20.010 - LOT #2112836 - STER.# 2100239. BONE SCREW Ø6,5 H.30MM, COMMERCIAL CODE 8420.15.030 - LOT #2115058 - STER. #2100236. BONE SCREW Ø6,5 H.35MM, COMMERCIAL CODE 8420.15.040 - LOT #2016866 - STER. #2000322. PREVIOUS SURGERY DATE - (B)(6)2021. PATIENT - MALE. DATE OF BIRTH - (B)(6) 1957. EVENT OCCURRED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1874847 SMR REVERSE FINNED HUMER. BODY SMR REVERSE FINNED HUMER. BODY PHX LIMACORPORATE S.P.A 1352.15.050 2105488

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention