BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 15860521 · Received November 24, 2022

    Report

    Report Number
    3005180920-2022-00904
    Event Type
    Injury
    Date Received
    November 24, 2022
    Date of Event
    November 7, 2022
    Report Date
    November 24, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706261
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 14-NOV-2022, LOT 2203298: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-MAY-2022. EXPIRATION DATE: 2027-04-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. NO COMMENT CAN BE MADE BASED ON THE PROVIDED PICTURES. NO BONE RESIDUALS ARE VISIBLE ON THE COATED AREA. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 14-NOV-2022 REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT. 2114058. LOT 2114058: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-MAY-2022. EXPIRATION DATE: 2027-04-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0182 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 9 (K180089) LOT. 2009928. LOT 2009928: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-DEC-2020. EXPIRATION DATE: 2025-12-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0172 GLENOSPHERE 36XØ27 (K170452) LOT. 2115873. LOT 2115873: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-MAR-2022. EXPIRATION DATE: 2027-03-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, A REVISION WAS PERFORMED DUE TO WOUND INFECTION. THE LINER, STEM, METAPHYSIS SCREW AND THE GLENOSPHERE WERE REVISED SUCCESSFULLY. THE SURGEON REVISED ALSO THE STEM BECAUSE IT MOBILIZED DURING LINER REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1897674 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+0MM HUMERAL REVERSE HC LINER PHX MEDACTA INTERNATIONAL SA 04.01.0119 2203298 07630040706261

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention