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

Catalog Number	04.01.0155
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 october 2019: lot 175039: (b)(4) items manufactured and released on 07-mar-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 with one similar event reported.Additional devices involved.Batch reviews performed on 17 october 2019: reverse shoulder system 04.01.0162 glenoid polyaxial locking screw - l34 (k170452) lot 174748: (b)(4) items manufactured and released on 30-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 similar reported event.Reverse shoulder system 04.01.0163 glenoid polyaxial locking screw - l38 (k170452) lot 174286: (b)(4) items manufactured and released on 12-oct-2017.Expiration date: 2022-10-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one other similar event reported.Reverse shoulder system 04.01.0174 glenosphere 42x27 (k170452) lot 163806: (b)(4) items manufactured and released on 20-dec-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.Reverse shoulder system 04.01.0127 humeral reverse hc liner ø42/+6mm (k170452) lot 173411: 72 items manufactured and released on 21-jun-2017.Expiration date: 2022-05-31.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 04.01.0158 glenoid polyaxial locking screw - l18 (k170452) lot 182473: (b)(4) items manufactured and released on 04-sep-2018.Expiration date: 2023-08-22.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 04.01.0006 std humeral diaphysis - cementless - 11 (k170452) lot 178132: (b)(4) items manufactured and released on 29-mar-2018.Expiration date: 2023-03-08.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.Reverse shoulder system 04.01.0110 reverse methaphysis +0mm/0° (k170452) lot 174650: 152 items manufactured and released on 5-feb-2018.Expiration date: 2023-01-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with two other similar events reported.
Event or Problem Description
On (b)(6) the patient refluxated (the patient have a complex clinical history, he is spastic).On (b)(6) all the implants have been explanted due to infection.New implants have been implanted on (b)(6) 2019, 4 months after primary surgery.Revision surgery completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X25
• Common Device Name: SHOULDER GLENOID BASEPLATE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9254778
• Report Number: 3005180920-2019-00925
• Device Sequence Number: 2550638
• 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
• Report Date (Section B): 10/30/2019

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 Catalogue Number: 04.01.0155
• Device Lot Number: 175039
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 10/30/2019
• 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