BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X15

    MDR report key: 7412279 · Received April 10, 2018

    Report

    Report Number
    3005180920-2018-00221
    Event Type
    Injury
    Date Received
    April 10, 2018
    Date of Event
    March 13, 2018
    Report Date
    April 10, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706414
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 APRIL 2018; LOT 163782: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 DECEMBER 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. GLENOID POLYAXIAL LOCKING SCREW - L22 REFERENCE 04.01.0159 (K170452); LOT 165150: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 DECEMBER 2016. EXPIRATION DATE: 2021-11-03. 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. GLENOID POLYAXIAL LOCKING SCREW - L18 REFERENCE 04.01.0158 (K170452); LOT 165149 : (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 DECEMBER 2016. EXPIRATION DATE: 2021-11-03 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. STD HUMERAL DIAPHYSIS - CEMENTLESS - 12 REFERENCE 04.01.0007 (K170452); LOT 164509 : (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 DECEMBER 2016. EXPIRATION DATE: 2021-09-06; 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. GLENOSPHERE 39XØ27 REFERENCE 04.01.0173 (K170452); LOT 163804 : (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 DECEMBER 2016. EXPIRATION DATE: 2021-11-08; 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. GLENOID POLYAXIAL LOCKING SCREW - L26 REFERENCE 04.01.0160 (K170452); LOT 165151: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 DECEMBER 2016. EXPIRATION DATE: 2021-11-06. 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. HUMERAL REVERSE HC LINER Ø39/+0MM REFERENCE 04.01.0122 (K170452); LOT 163769: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 DECEMBER 2016. EXPIRATION DATE: 2021-09-08; 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

    ABOUT 8 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT SHOULDER FOR AN INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259130 REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X15 GLENOID BASEPLATE PHX MEDACTA INTERNATIONAL SA 163782 07630040706414

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention