BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+6MM

    MDR report key: 18244578 · Received December 1, 2023

    Report

    Report Number
    3005180920-2023-00941
    Event Type
    Injury
    Date Received
    December 1, 2023
    Date of Event
    November 2, 2023
    Report Date
    December 1, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706315
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY CLINICAL AFFAIRS DEPARTMENT. REVISION SURGERY 5 DAYS AFTER THE INDEX SURGERY DUE TO SHOULDER LUXATION. FOR THE PATIENT THIS WAS THE SECOND REVISION, THE FIRST REVISION WAS DONE DUE TO FAILURE OF IMPLANTS OF ANOTHER MANUFACTURER. ACCORDING TO REPORT THE STEM WAS REMOVED RELATIVELY EASILY AND IT WAS REPLACED AS WELL: AFTER 5 DAYS, IT IS DIFFICULT TO ESTABLISH IF THE LOSS OF INITIAL PRESS FIT STABILITY WAS PHYSIOLOGICAL OR ABNORMAL; HOWEVER, HAVING BEEN REPLACED, THE QUESTION IS NO LONGER RELEVANT TO THIS CASE. JOINT DISLOCATIONS ARE NORMALLY ORIGINATED BY INSUFFICIENT RE-ESTABLISHMENT OF SOFT TISSUE TENSION AFTER THE OPERATION. NO FURTHER CONCLUSION CAN BE DRAWN WITH THE ELEMENTS AT HAND. BATCH REVIEW PERFORMED ON 14 NOVEMBER 2023: LOT 2004294: (B)(4) MANUFACTURED AND RELEASED ON 16-JUL-2020. EXPIRATION DATE: 2025-07-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ADDITIONAL COMPONENTS INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0208 LAT. GLENOSPHERE 39XØ24.5 (K193175) LOT. 2117712: (B)(4) MANUFACTURED AND RELEASED ON 05-APR-2022. EXPIRATION DATE: 2027-03-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0216 LONG HUMERAL DIAPHYSIS - L160 - 9 (K192967) LOT. 2212706: (B)(4) MANUFACTURED AND RELEASED ON 13-SEP-2022. EXPIRATION DATE: 2027-08-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY FOR SHOULDER LUXATION 5 DAYS AFTER PRIMARY. INTRAOPERATIVELY, THE STEM COULD BE REMOVED RELATIVELY EASILY AND IT WAS REPLACED AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1451060 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+6MM SHOULDER REVERSE HUMERAL LINER PHX MEDACTA INTERNATIONAL SA 2004294 07630040706315

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention