MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM STD HUMERAL DIAPHYSIS - CEMENTLESS - 10; SHOULDER UNCEMENTED DIAPHZSIS

Model Number	04.01.0005
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed 1 year and 2 months after the primary surgery, due to low grade infection (pathogen unknown).
Additional Manufacturer Narrative
Batch review performed on 17 may 2022: lot 2006059: (b)(4) items manufactured and released on 19-oct-2020.Expiration date: 2025-oct-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Additional devices involved.Batch reviews performed on 17 may 2022: reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot 2003391: (b)(4) items manufactured and released on 30-sep-2020.Expiration date: 2025-oct-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Reverse shoulder system 04.01.0152 glenoid baseplate ø24.5x25 (k170452) lot 2005435: (b)(4) items manufactured and released on 16-oct-2020.Expiration date: 2025-oct-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Reverse shoulder system 04.01.0169 glenosphere 36xø24.5 (k170452) lot 2003842a: (b)(4) items manufactured and released on 21-dec-2020.Expiration date: 2025-dec-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Reverse shoulder system 04.01.0119 humeral reverse hc liner ø36/+0mm (k170452) lot 2008850: (b)(4) items manufactured and released on 21-nov-2020.Expiration date: 2025-oct-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Reverse shoulder system 04.01.0158 glenoid polyaxial locking screw - l18 (k170452) lot 1909106: (b)(4) items manufactured and released on 13-dec-2019.Expiration date: 2024-dec-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Reverse shoulder system 04.01.0160 glenoid polyaxial locking screw - l26 (k170452) lot 2005659: (b)(4) items manufactured and released on 03-aug-2020.Expiration date: 2025-jul-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Clinical evaluation performed by medacta clinical affairs specialist: late infection in rsa, 1 year after primary operation.Infection is a known possible adverse event following every surgery, including rsa's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.

• Brand Name: REVERSE SHOULDER SYSTEM STD HUMERAL DIAPHYSIS - CEMENTLESS - 10
• Common Device Name: SHOULDER UNCEMENTED DIAPHZSIS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14591438
• Report Number: 3005180920-2022-00441
• Device Sequence Number: 2057885
• Product Code: PHX
• UDI-Device Identifier: 07630040706049
• UDI-Public: 07630040706049
• 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: 2022
• 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): 06/03/2022

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: 10/07/2025
• Device Model Number: 04.01.0005
• Device Catalogue Number: 04.01.0005
• Device Lot Number: 2006059
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2020
• 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: 83 YR
• Patient Sex: Female
• Patient Weight: 105 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White