MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+6MM; REVERSE SHOULDER LINER

Model Number	04.01.0121
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15.February.2021: lot 2004291: (b)(4) items manufactured and released on 23-jul-2020.Expiration date: 2025-07-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional implant involved: reverse shoulder system 04.01.0111 humeral reverse metaphysis +9mm/0¿ (k170452), lot.1910965.Batch review performed on 15.February.2021: lot 1910965: (b)(4) items manufactured and released on 10-jun-2020.Expiration date: 2025-05-28.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.Additional implant involved: reverse shoulder system 04.01.0207 lat.Glenosphere 36x¿24.5 (k193175) lot.189933 batch review performed on 15.February.2021: lot 189933: 55 items manufactured and released on 08-may-2019.Expiration date: 2024-04-23.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.Additional implant involved: reverse shoulder system 04.01.0190 threaded glenoid baseplate ¿24.5x25 (k171058 ) lot.1811892 batch review performed on 15.February.2021: lot 1811892: (b)(4) items manufactured and released on 17-jul-2019.Expiration date: 2024-07-01.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.Additional implant involved: reverse shoulder system 04.01.0001 std humeral diaphysis - cementless - 6 (k170452) lot.1906537 batch review performed on 15.February.2021: lot 1906537: (b)(4) items manufactured and released on 12-sep-2019.Expiration date: 2024-08-28.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.
Event or Problem Description
The patient came in 1 month after the previous revision surgery due to signs of an infection and the pathogen is unknown.The surgeon removed all hardware and implanted an antibiotic spacer.The surgery was completed successfully.The previous revision surgery was performed due to dislocation( glenosphere and liner revised).The primary surgery was performed on (b)(6) 2020.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+6MM
• Common Device Name: REVERSE SHOULDER LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11337935
• Report Number: 3005180920-2021-00123
• Device Sequence Number: 3483736
• Product Code: PHX
• UDI-Device Identifier: 07630040706285
• UDI-Public: 07630040706285
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2021

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: 07/13/2025
• Device Model Number: 04.01.0121
• Device Catalogue Number: 04.01.0121
• Device Lot Number: 2004291
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 02/17/2021
• 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