BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR REVERSE RETENTIVE LINER D. 40MM +6MM

    MDR report key: 14425874 · Received May 17, 2022

    Report

    Report Number
    3008021110-2022-00038
    Event Type
    Injury
    Date Received
    May 17, 2022
    Date of Event
    April 27, 2022
    Report Date
    October 18, 2023
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    PHX
    PMA / PMN Number
    K142139
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING RECORDS WERE CHECKED CONFIRMING THE BATCH NUMBER INVOLVED WAS MANUFACTURED CORRECTLY UP TO SPECIFICATION AND IN-LINE WITH THE RELEVANT CHECKS AND TESTS. NO MANUFACTURING DEVIATIONS WERE REPORTED. WE WILL SEND A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION MANUFACTURING RECORDS WERE CHECKED CONFIRMING THE BATCH NUMBER INVOLVED WAS MANUFACTURED CORRECTLY UP TO SPECIFICATION AND IN-LINE WITH THE RELEVANT CHECKS AND TESTS. NO MANUFACTURING DEVIATIONS WERE REPORTED. ACCORDING TO THE LABELLING OF SMR REVERSE HUMERAL BODY 140°, FOR THIS COMPONENT THE COUPLING IS ONLY ALLOWED WITH LINERS BELONGING TO THE CODES 1360.50.0XX, 1361.50.0XX, 1360.50.8XX, 1361.50.8XX. THEREFORE, THE COUPLING WITH A REVERSE LINER WITH PRODUCT CODE 1365.50.821 SHOULD BE CONSIDERED AN OFF-LABEL USE. EXPLANTS AND X-RAYS ANALYSIS THE EXPLANTS ARE NOT AVAILABLE FOR FURTHER INVESTIGATION. HOWEVER, THE COMPLAINT SOURCE SHARED THE RELEVANT X-RAYS, THAT HAVE BEEN SENT TO THE MEDICAL EXPERT FOR EVALUATION. BASED ON HIS OPINION, "THIS IS A CASE OF SURGICAL ERROR INDUCED DISSOCIATION OR INSTABILITY". " LOOSENING OF A LINER ALMOST ALWAYS IS A SURGICAL ERROR BY NOT ENGAGING THE CONICAL TAPER CORRECTLY. WHEN THERE IT IS HARD TO PROVE AFTERWARDS, THE AFOREMENTIONED FACTS GIVE SOME IDEA THAT A SURGICAL ERROR IS THE MOST LIKELY REASON FOR THIS EARLY REVISION. I CANNOT SEE AN IMPLANT-RELATED PROBLEM HERE." THEREFORE, CONSIDERING THAT: - NO ANOMALIES HAVE BEEN FOUND BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED COMPONENT. - ACCORDING TO THE MEDICAL EXPERT'S EVALUATION, A SURGICAL ERROR IS THE MOST LIKELY REASON FOR THIS REVISION AND THERE IS NO EVIDENCE OF IMPLANT-RELATED CONCERNS. WE CAN CONCLUDE THAT THE ISSUE IS NOT PRODUCT RELATED. PMS DATA ACCORDING TO THE PMS DATA, THE OCCURRENCE RATE OF DISLOCATION FOR THE SMR REVERSE LINERS BELONGING TO THE PRODUCT FAMILY CODES 1360.50.XXX, 1361.50.XXX AND 1365.50.XXX IS AROUND (B)(4) %. NO CORRECTIVE ACTIONS ARE 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

    SMR REVERSE REVISION SURGERY PERFORMED ON (B)(6) 2022 DUE TO DISASSOCIATION OF THE REVERSE LINER - PRODUCT CODE 1365.50.821, LOT 21AT0FB, STER 2100270 FROM THE 140° REVERSE HUMERAL BODY. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022. EVENT HAPPENED IN US.

    Description of Event or Problem · 0

    SMR REVERSE REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO DISASSOCIATION OF THE REVERSE LINER - PRODUCT CODE 1365.50.821, LOT 21AT0FB, STERILIZATION (B)(6) FROM THE 140° REVERSE HUMERAL BODY. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022.EVENT HAPPENED IN UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1502693 SMR REVERSE RETENTIVE LINER D. 40MM +6MM REVERSE RETENTIVE LINER D. 40MM +6MM PHX LIMACORPORATE S.P.A. 1365.50.821 21AT0FB

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention