BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+0MM

    MDR report key: 16730509 · Received April 13, 2023

    Report

    Report Number
    3005180920-2023-00246
    Event Type
    Injury
    Date Received
    April 13, 2023
    Date of Event
    March 17, 2023
    Report Date
    April 13, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706261
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2023. LOT 2215670: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-OCT-2022. EXPIRATION DATE: 2027-09-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENTS INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0169 GLENOSPHERE 36XØ24.5 (K170452) LOT. 2201462: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAY-2022. EXPIRATION DATE: 2027-05-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0003 STD HUMERAL DIAPHYSIS - CEMENTLESS - 8 (K170452) LOT 2215122: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-OCT-2022. EXPIRATION DATE: 2027-08-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 8 DAYS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO SHOULDER LUXATION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED GLENOSPHERE AND LINER. DURING THE REVISION SURGERY, IT WAS ALSO NOTED THAT THE DIAPHYSIS WAS NOT WELL FIXED. SO THE SURGEON REMOVED METAPHYSIS AND DIAPHYSIS, RECUT A BIT OF THE BONE, REBROACHED AND PUT IN A NEW STEM (SAME SIZE) THAT WAS SUNK IN DEEPER AND HAD A BETTER BITE TO THE BONE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1456500 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+0MM SHOULDER LINER REVERSE SYSTEM PHX MEDACTA INTERNATIONAL SA 04.01.0119 2215670 07630040706261

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention