BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR REVERSE LINER RETENTIVE

    MDR report key: 14425887 · Received May 17, 2022

    Report

    Report Number
    3008021110-2022-00039
    Event Type
    Injury
    Date Received
    May 17, 2022
    Date of Event
    April 22, 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, "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 0,020%. 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 APRIL 22ND, 2022 DUE TO DISASSOCIATION OF SMR REVERSE LINER - PRODUCT CODE 1365.50.821, LOT 21AT0FB, STER 2100270 FROM 140° REVERSE HUMERAL BODY. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022. EVENT HAPPENED IN THE US.

    Description of Event or Problem · 0

    SMR REVERSE REVISION SURGERY PERFORMED ON (B)(6) 2022 DUE TO DISASSOCIATION OF SMR REVERSE LINER - PRODUCT CODE 1365.50.821, LOT 21AT0FB, STER (B)(6) FROM 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
    1502700 SMR REVERSE LINER RETENTIVE REVERSE RETENTIVE LINER 40MM +6MM PHX LIMACORPORATE S.P.A. 1365.50.821 21AT0FB

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention