BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM

    MDR report key: 8836271 · Received July 29, 2019

    Report

    Report Number
    3005180920-2019-00644
    Event Type
    Injury
    Date Received
    July 29, 2019
    Date of Event
    July 8, 2019
    Report Date
    July 29, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706292
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 19 JULY 2019: LOT 173418: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 3.07.2017. EXPIRATION DATE: 2022-06-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: SHOULDER DISLOCATION OCCURRED FEW MONTHS AFTER REVERSE SHOULDER ARTHROPLASTY. THESE EVENTS ARE NORMALLY ORIGINATED BY PROGRESSION OF DISEASE TO THE SOFT TISSUES OR INSUFFICIENT RE-ESTABLISHMENT OF SOFT TISSUE TENSION AFTER THE OPERATION. NO FURTHER CONCLUSION CAN BE DRAWN WITH THE ELEMENTS AT HAND. ADDITIONAL IMPLANT INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 19 JULY 2019. REVERSE SHOULDER SYSTEM 04.01.0003 STD HUMERAL DIAPHYSIS - CEMENTLESS - 8 (K170452) LOT. 176936. LOT 176936: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30.11.2017. EXPIRATION DATE: 2022-11-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED AFTER 4 MONTHS FROM THE PRIMARY DUE TO PAIN CAUSED BY A DISLOCATION OF THE GLENOSPHERE FROM THE LINER (THE CAUSE OF THE DISLOCATION IS UNKNOWN, NO SIGN OF INFECTION PRESENT). THE SURGEON REVISED THE STEM, LINER AND METAPHISIS SUCCESSFULLY. THE STEM SIZE HAS BEEN REDUCED FROM 8 TO 6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629305 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM REVERSE SHOULDER HUMERAL HC LINER PHX MEDACTA INTERNATIONAL SA 173418 07630040706292

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention