BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 10

    MDR report key: 10493615 · Received September 4, 2020

    Report

    Report Number
    3005180920-2020-00578
    Event Type
    Injury
    Date Received
    September 4, 2020
    Date of Event
    August 17, 2020
    Report Date
    October 6, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040715911
    PMA / PMN Number
    K180089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 13.08.2020: LOT 2000897: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 6-MAY-2020. EXPIRATION DATE: 2025-04-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION: REVISION SURGERY DUE TO DISLOCATION AFTER REVERSE SHOULDER ARTHROPLASTY. THESE EVENTS 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.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED DUE TO DISLOCATION CAUSED BY STEM SUBSIDENCE ONE MONTH AFTER THE PRIMARY SURGERY. PROBABLY THE STEM WAS INSERTED A BIT TOO DEEPLY DURING THE PRIMARY SURGERY AND ALSO SUBSIDED AFTER THE PRIMARY SURGERY, WHAT CAUSED THAT THE STEM WAS FINALLY 3MM BELOW RESPECT TO THE PLANNED POSITION. THE LINER +0MM WAS REVISED WITH +3MM.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGUALTORY AFFAIRS DEPARTMENT ON 13.AUG.2020: LOT 1910855: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-MAR-2020. EXPIRATION DATE: 2025-03-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATON PERFORMED BY MEDICAL AFFAIRS MANAGER: REVISION SURGERY DUE TO DISLOCATION AFTER REVERSE SHOULDER ARTHROPLASTY. THESE EVENTS 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. ADDITIONAL IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0119 HUMERAL REVERSE HC LINER Ø36/+0MM (K170452) LOT. 1910872. BATCH REVIEW PERFORMED BY MEDACTA REGUALTORY AFFAIRS DEPARTMENT ON 13.AUG.2020: LOT 1910872: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MAR-2020. EXPIRATION DATE: 2025-02-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0169 GLENOSPHERE 36XØ24.5 (K170452) LOT. 1811894. BATCH REVIEW PERFORMED BY MEDACTA REGUALTORY AFFAIRS DEPARTMENT ON 13.AUG.2020: LOT 1811894: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-MAZ-2019. EXPIRATION DATE: 2024-05-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE SURGEON DISCOVERED THE DISLOCATION DURING A ROUTINE CHECKUP AT THE X-RAY 1 MONTH AFTER THE PRIMARY SURGERY. THE DISLOCATION WAS CAUSED BY THE SUBSIDENCE OF THE STEM (3MM BELOW RESPECT TO THE POSITION DURING THE PRIMARY SURGERY) PROBABLY CAUSED BY A TECHNICAL ERROR. THE LINER +0MM WAS REVISED WITH +3MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960154 REVERSE SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 10 CEMENTLESS HUMERAL DIAPHYSIS PHX MEDACTA INTERNATIONAL SA 2000897 07630040715911

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention