BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0

    MDR report key: 11444821 · Received March 9, 2021

    Report

    Report Number
    3005180920-2021-00169
    Event Type
    Injury
    Date Received
    March 9, 2021
    Date of Event
    February 10, 2019
    Report Date
    March 9, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706179
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09.MARCH.2021: LOT 1903162: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-AUG-2019. EXPIRATION DATE: 2024-07-23. 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. ADDITIONAL DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 09.MARCH.2021: REVERSE SHOULDER SYSTEM 04.01.0122 HUMERAL REVERSE HC LINER Ø39/+0MM (K170452) LOT 189835: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JAN-2019. EXPIRATION DATE: 2024-01-07. 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. REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE 39XØ27 (K170452) LOT 179113: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-MAR-2018. EXPIRATION DATE: 2023-03-07. 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. REVERSE SHOULDER SYSTEM 04.01.0008 STD HUMERAL DIAPHYSIS - CEMENTLESS - 13 (K170452) LOT 164510: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-DEC-2016. EXPIRATION DATE: 2021-08-30. 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 SINCE 2017. REVERSE SHOULDER SYSTEM 04.01.0156 GLENOID BASEPLATE Ø27X35 (K170452) LOT 163784: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-DEC-2016. EXPIRATION DATE: 2021-08-29. 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 SINCE 2017. REVERSE SHOULDER SYSTEM 04.01.0198 GLENOID POLYAXIAL NON-LOCKING SCREW - L30 (K181826) LOT 1903173: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 2-JUL-2019. EXPIRATION DATE: 2024-06-19. 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. REVERSE SHOULDER SYSTEM 04.01.0200 GLENOID POLYAXIAL NON-LOCKING SCREW - L38 (K181826) LOT 187767: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JAN-2019. EXPIRATION DATE: 2023-12-17. 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 1 YEAR AND 4 MONTHS AFTER THE PRIMARY SURGERY DUE TO AN INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON REVISED ALL THE DEVICES SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340133 REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0 SHOULDER METAPHYSIS PHX MEDACTA INTERNATIONAL SA 04.01.0110 1903162 07630040706179

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention