MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø27X35

Model Number	04.01.0193
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 24 april 2020: lot 185296: (b)(4) items manufactured and released on 29-aug-2018.Expiration date: 2023-08-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported.Additional items involved in the event, batch review performed on 24 april 2020: reverse shoulder system 04.01.0158 glenoid polyaxial locking screw - l18 (k170452) lot.182473.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 with one similar reported event.Reverse shoulder system 04.01.0161 glenoid polyaxial locking screw - l30 (k170452) lot.182475.Lot 182475: (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 with two similar reported events.Reverse shoulder system 04.01.0172 glenosphere 36xø27 (k170452) lot.174733.Lot 174733: (b)(4) items manufactured and released on 26-sep-2017.Expiration date: 2022-09-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported events.Reverse shoulder system 04.01.0121 humeral reverse hc liner ø36/+6mm (k170452) lot.179979.179979: (b)(4) items manufactured and released on 19-apr-2018.Expiration date: 2023-04-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported events.Reverse shoulder system 04.01.0111 humeral reverse metaphysis +9mm/0° (k170452) lot.184050.Lot 184050: (b)(4) items manufactured and released on 26-oct-2018.Expiration date: 2023-10-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported events.Reverse shoulder system 04.01.0008 std humeral diaphysis - cementless - 13 (k170452) lot.179097.Lot 179097: (b)(4) items manufactured and released on 11-apr-2018.Expiration date: 2023-03-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported events.
Event or Problem Description
The patient came in 9 months after the primary surgery due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and removed all implants and inserted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø27X35
• Common Device Name: THREADED GLENOID BASEPLATE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; CH 6874
• MDR Report Key: 10051230
• Report Number: 3005180920-2020-00280
• Device Sequence Number: 2743294
• Product Code: PHX
• UDI-Device Identifier: 07630040715492
• UDI-Public: 07630040715492
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/13/2020

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: 08/23/2021
• Device Model Number: 04.01.0193
• Device Catalogue Number: 04.01.0193
• Device Lot Number: 185296
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 05/13/2020
• 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