MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X25; SHOULDER GLENOID BASEPLATE Ø27X25

Model Number	04.01.0155
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 october 2019: lot 175039: 100 items manufactured and released on 07-mar-2018.Expiration date: 2023-02-26.No anomalies found related to the problem.To date, 65 items of the same lot have been already sold with 3 other similar events.Other implants involved in the complaint, batch review performed on 25 october 2019: reverse shoulder system 04.01.0162 glenoid polyaxial locking screw - l34 lot.179106 sn n/a lot 179106: 150 items manufactured and released on 23-apr-2018.Expiration date: 2023-04-09.No anomalies found related to the problem.To date, 105 items of the same lot have been already sold without any similar reported event.2 devices of this lot involved in this complaint.Reverse shoulder system 04.01.0161 glenoid polyaxial locking screw - l30 lot.182475 lot 182475: 450 items manufactured and released on 04-sept-2018.Expiration date: 2023-08-22.No anomalies found related to the problem.To date, 368 items of the same lot have been already sold without any similar reported event.Reverse shoulder system 04.01.0163 glenoid polyaxial locking screw - l38 lot.174750 lot 174750: 149 items manufactured and released on 01-mar-2018.Expiration date: 2023-02-13.No anomalies found related to the problem.To date, 81 items of the same lot have been already sold without any similar reported event.Reverse shoulder system 04.01.0162 glenoid polyaxial locking screw - l34 lot.174748 lot 174748: 200 items manufactured and released on 30-jun-2018.Expiration date: 2023-01-16.No anomalies found related to the problem.To date, 148 items of the same lot have been already sold with another similar even reported.Reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° lot.174654 lot 174654: 104 items manufactured and released on 20-mar-2018.Expiration date: 2023-03-07.No anomalies found related to the problem.To date, 99 items of the same lot have been already sold without any similar reported event.Reverse shoulder system 04.01.0004 std humeral diaphysis - cementless - 9 lot.179096 lot 179096: 20 items manufactured and released on 29-mar-2018.Expiration date: 2023-03-13.No anomalies found related to the problem.To date, 12 items of the same lot have been already sold without any similar reported event.Reverse shoulder system 04.01.0127 humeral reverse hc liner ø42/+6mm lot.179984 lot 179984: 120 items manufactured and released on 24-apr-2018.Expiration date: 2023-04-09.No anomalies found related to the problem.To date, 17 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision surgery 4 months after primary for infection, all hardware removed successfully.This patient comes from a very complex clinical history with multiple precedent intervention on the shoulder.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X25
• Common Device Name: SHOULDER GLENOID BASEPLATE Ø27X25
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9321301
• Report Number: 3005180920-2019-00958
• Device Sequence Number: 387880
• Product Code: PHX
• UDI-Device Identifier: 07630040706421
• UDI-Public: 07630040706421
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/26/2023
• Device Model Number: 04.01.0155
• Device Catalogue Number: 04.01.0155
• Device Lot Number: 175039
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 02/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR