BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR GLENOID BASEPLATE SMALL-R

    MDR report key: 12106178 · Received July 2, 2021

    Report

    Report Number
    3008021110-2021-00052
    Event Type
    Injury
    Date Received
    July 2, 2021
    Date of Event
    June 21, 2021
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    KWS
    PMA / PMN Number
    K133349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS OF THE SMR REVERSE HP GLENOSPH. 40 MM CODE 1374.50.400 LOT 2020162 STER 2000341 WAS CHECKED WITHOUT FINDING ANY PRE- EXISTING ANOMALY. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THE SAME PRODUCTION LOT#. THE STERILIZATION CHARTS OF ALL THE COMPONENTS THAT HAVE BEEN EXPLANTED DURING THE REVISION SURGERY WERE ALSO CHECKED AND NO PRE-EXISTING ANOMALY WAS FOUND, THUS WE CAN STATE THAT THEY HAD BEEN REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. NO OTHER CASES OF INFECTION REGISTERED ON THE STERILIZATION LOT#S INVOLVED IN THIS COMPLAINT. VERY FEW INFORMATION IS AVAILABLE ON THIS CASE, SPECIFICALLY: THE EXPLANTED COMPONENTS WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR A SPECIFIC ANALYSIS, THE PRE-OPERATIVE X-RAYS OF THE REVISION SURGERY AND THE POST-OPERATIVE X-RAYS OF THE PREVIOUS SURGERY WERE NOT AVAILABLE, THUS NO FURTHER CLINICAL EVALUATION BY LIMA MEDICAL CONSULTANT COULD BE PERFORMED. BASED ON THE KNOWN DETAILS, WE CANNOT DETERMINE THE CAUSE OF THE DISLOCATION AND THE INFECTION REPORTED, HOWEVER, THE CHECK OF THE PRODUCTION/STERILIZATION DOCUMENTS CONFIRMED THE ABSENCE OF PRE-EXISTING ANOMALY ON THE INVOLVED COMPONENTS. THIS EVENT CANNOT BE CLASSIFIED AS PRODUCT-RELATED. PMS DATA: BASED ON LIMACORPORATE PMS DATA, THE REVISION RATE OF SMR REVERSE PROSTHESIS DUE TO DISLOCATION IS 0,12% AND THE REVISION RATE OF SMR REVERSE PROSTHESIS DUE TO INFECTION IS 0.05%. NO SPECIFIC ACTION FOR THIS CASE, LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR EVENT. NOTE: THIS IS AN INITIAL-FINAL MDR.

    Description of Event or Problem · 1

    SHOULDER REVISION SURGERY DUE TO DISLOCATION PERFORMED ON (B)(6) 2021, WITH REMOVAL OF THE FOLLOWING COMPONENTS: SMR REVERSE HP GLENOSPH. 40 MM 137450400 LOT 2020162 STER 2000341 (NOT MARKETED IN USA) SMR GLENOID PEG TT SMALL-R #L 137514653 LOT 2007769 STER 2000264. SMR GLENOID BASEPLATE SMALL-R 137515605 LOT 2016581 STER 2000346. SMR REVERSE HUMERAL BODY 135220010 LOT 2100584 STER 2100068. SMR REVERSE HP LINER MEDIUM 136509015 LOT 2101024 STER 2100088 (NOT MARKETED IN USA). SMR CONNECTOR SMALL R 137415305 LOT 2103804 STER 2100093. THE PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2021. ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT PRESENTED AT THE FOLLOW UP VISIT WITH AN ANTERIOR DISLOCATION, UNDERWENT AN OPEN REDUCTION AND THEN RE DISLOCATED AGAIN THE NEXT DAY. DURING THE REVISION SURGERY, THE LINER WAS CHANGED TO A RETENTIVE ONE (CODE 1365.50.816), AN EXTENSION FOR REVERSE HUMERAL BODY (CODE 1352.15.001) WAS ADDED, THE GLENOSPHERE WAS CHANGED TO AN ECCENTRICAL 40MM (CODE 1376.09.040). THE HUMERAL BODY, GLENOID BASEPLATE AND THE GLENOID PEG WERE ALSO REPLACED. BESIDES, THE VERSION OF THE HUMERUS WAS CHANGED. THE SURGEON COMMENTED THAT THE PATIENT HAD LOTS OF HETEROTOPIC OSSIFICATION AND THAT THE GLENOID WAS ALSO LOOSE. MOREOVER, HE HAS C ACNES INFECTION. PATIENT IS MALE, (B)(6), ACTIVE. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005276 SMR GLENOID BASEPLATE SMALL-R SMR GLENOID BASEPLATE SMALL-R KWS LIMACORPORATE SPA 1375.15.605 2016581

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention