BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOSPHERE 42X27

    MDR report key: 11320738 · Received February 12, 2021

    Report

    Report Number
    3005180920-2021-00117
    Event Type
    Injury
    Date Received
    February 12, 2021
    Date of Event
    January 16, 2021
    Report Date
    February 12, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706612
    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 10 FEBRUARY 2021: LOT 179115: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-MARCH-2018. EXPIRATION DATE: 2023-03-05. 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 DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 10 FEBRUARY 2021: REVERSE SHOULDER SYSTEM 04.01.0154 GLENOID BASEPLATE Ø27X15 (K170452) .LOT 175035: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-MARCH-2018. EXPIRATION DATE: 2023-02-26. 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. REVERSE SHOULDER SYSTEM 04.01.0126 HUMERAL REVERSE HC LINER Ø42/+3MM (K170452). LOT 179983: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-APRIL-2018. EXPIRATION DATE: 2023-04-09. 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. REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452). LOT 174649: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-DEC-2017. EXPIRATION DATE: 2022-11-28. 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. REVERSE SHOULDER SYSTEM 04.01.0126 HUMERAL REVERSE HC LINER Ø42/+3MM (K170452). LOT 179983: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-APRIL-2018. EXPIRATION DATE: 2023-04-09. 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. REVERSE SHOULDER SYSTEM 04.01.0182 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 9 (K180089). LOT 182487: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAY-2018. EXPIRATION DATE: 2023-05-01. 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. REVERSE SHOULDER SYSTEM 04.01.0158 GLENOID POLYAXIAL LOCKING SCREW - L18 (K170452). LOT 174740: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-DEC-2017. EXPIRATION DATE: 2022-12-06. 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. REVERSE SHOULDER SYSTEM 04.01.0160 GLENOID POLYAXIAL LOCKING SCREW - L26 (K170452). LOT 174742: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JAN-2018. EXPIRATION DATE: 2023-01-16. 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. REVERSE SHOULDER SYSTEM 04.01.0159 GLENOID POLYAXIAL LOCKING SCREW - L22 (K170452). LOT 174741: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-JAN-2018. EXPIRATION DATE: 2022-12-28. 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

    REVISION SURGERY 2 YEARS AND 6 MONTHS AFTER PRIMARY DUE TO INFECTION FROM THE HEMATOGENIC SOURCE. THE SURGEON REVISED ALL IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222296 REVERSE SHOULDER SYSTEM GLENOSPHERE 42X27 SHOULDER REVERSE GLENOSPHERE PHX MEDACTA INTERNATIONAL SA 04.01.0174 179115 07630040706612

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention