MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM 04.01.0155 GLENOID BASEPLATE Ø27X25; SHOULDER GLENOID BASEPLATE

Model Number	04.01.0155
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	03/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery for infection at about 2 years and 1 month after primary.The surgeon revised successfully all the devices.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2023: lot 2006582: (b)(4) items manufactured and released on 11-nov-2020.Expiration date: 2025-11-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Other devices involved: reverse shoulder system 04.01.0163 glenoid polyaxial locking screw - l38 lot.2005661 (k170452): (b)(4) items manufactured and released on 26-aug-2020.Expiration date: 2025-08-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Reverse shoulder system 04.01.0161 glenoid polyaxial locking screw - l30 lot.2002443 (k170452): (b)(4) items manufactured and released on 01-july-2020.Expiration date: 2025-05-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Reverse shoulder system 04.01.0211 lat.Glenosphere 39xø27 lot.189945 (k193175): (b)(4) items manufactured and released on 14-may-2019.Expiration date: 2024-05-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Resterilized devices of this lot considered in this batch.Reverse shoulder system 04.01.0158 glenoid polyaxial locking screw - l18 lot.2002440 (k170452): (b)(4) items manufactured and released on 26-aug-2020.Expiration date: 2025-08-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event in the period of review.2 devices of this lot involved in this complaint.Reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° lot.2001815 (k170452): (b)(4) items manufactured and released on 16-oct-2020.Expiration date: 2025-10-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Reverse shoulder system 04.01.0158 glenoid polyaxial locking screw - l18 lot.2002440 (k170452): (b)(4) items manufactured and released on 26-aug-2020.Expiration date: 2025-08-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event in the period of review.2 devices of this lot involved in this complaint.Reverse shoulder system 04.01.0007 std humeral diaphysis - cementless - 12 lot.1910843 (k170452): (b)(4) items manufactured and released on 16-mar-2020.Expiration date: 2025-03-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Reverse shoulder system 04.01.0122 humeral reverse hc liner ø39/+0mm lot.2006593 (k170452): (b)(4) items manufactured and released on 12-nov-2020.Expiration date: 2025-10-29.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event in the period of review.

• Brand Name: REVERSE SHOULDER SYSTEM 04.01.0155 GLENOID BASEPLATE Ø27X25
• Common Device Name: SHOULDER GLENOID BASEPLATE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16680117
• Report Number: 3005180920-2023-00210
• Device Sequence Number: 8116176
• Product Code: PHX
• UDI-Device Identifier: 07630040706421
• UDI-Public: 07630040706421
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/05/2023

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: 11/02/2025
• Device Model Number: 04.01.0155
• Device Catalogue Number: 04.01.0155
• Device Lot Number: 2006582
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Race: White