BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 7

    MDR report key: 14191936 · Received April 25, 2022

    Report

    Report Number
    3005180920-2022-00315
    Event Type
    Injury
    Date Received
    April 25, 2022
    Date of Event
    April 1, 2022
    Report Date
    April 25, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040715881
    PMA / PMN Number
    K180089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 4 APRIL 2022. LOT 2100443: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-MAY-2021. EXPIRATION DATE: 2026-APR-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY CLINICAL AFFAIRS SPECIALIST. REVISION IN A RSA TWO DAYS AFTER THE INDEX SURGERY. THE PAIN REPORTED BY THE PATIENT MAY BE DUE TO STEM SUBSIDENCE. FROM THE RADIOGRAPHIC IMAGES, IT SEEMS THAT THE STEM IMPLANTED IN THE INDEX SURGERY WAS UNDERSIZED AND THIS MAY HAVE CAUSED THE STEM SUBSIDENCE. THE REASON OF THIS CHOICE IS UNKNOWN. NO FURTHER CONCLUSION CAN BE DRAWN WITH THE ELEMENTS AT HAND. INVESTIGATION PERFORMED BY R&D PROJECT MANAGER. THE STEM APPEARS TO BE QUALITATIVELY UNDERSIZED RELATIVE TO THE HUMERUS. HOWEVER, AS ALSO REPORTED IN THE SURGICAL TECHNIQUE, SIZING IS DONE BASED ON RASP STABILITY DURING HUMERAL PREPARATION AND IS THEN VERIFIED DURING STEM IMPINGEMENT. STABILITY DEPENDS ON BONE QUALITY AND IS NOT NECESSARILY GIVEN BY CONTACT WITH THE INTERNAL CORTICAL, SO LOOKING ONLY AT THE X-RAYS RECEIVED IT IS IMPOSSIBLE TO DEFINE THAT IT IS UNDERSIZED. BECAUSE WE DID NOT RECEIVE A POST-OP (OR INTRA-OP) X-RAY AND A PRE-REVISION X-RAY IN THE SAME PROJECTION, IT IS NOT POSSIBLE TO SAY WITH CERTAINTY THAT THIS IS STEM SUBSIDENCE OR WHETHER IT WAS IMPLANTED IN A PARTICULARLY 'INSET' POSITION.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO A HUMERAL STEM SUBSIDENCE DUE TO AN UNDERSIZED STEM. THE REASON FOR THE UNDERSIZED STEM IS UNKNOWN. AT 2 DAYS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE GLENOSPHERE, LINER, METAPHYSIS AND DIAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128391 REVERSE SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 7 CEMENTLESS HUMERAL DIAPHYSIS PHX MEDACTA INTERNATIONAL SA 04.01.0180 2100443 07630040715881

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention