MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+6MM; SHOULDER LINER

Model Number	04.01.0121
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 months after the primary, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the poly, stem, and glenosphere.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 18 january 2023: lot 2114977: 26 items manufactured and released on 18-feb-2022.Expiration date: 2027-01-02.No anomalies found related to the problem.To date, 14 items of the same lot have been sold without any similar reported event during the period of review.Additional devices involved batch reviews performed on 18 january 2023 reverse shoulder system 04.01.0207 lat.Glenosphere 36xø24.5 (k193175) lot 2201468: 41 items manufactured and released on 02-june-2022.Expiration date: 2027-05-09.No anomalies found related to the problem.To date, 33 items of the same lot have been sold without any similar reported event during the period of review.Reverse shoulder system 04.01.0008 std humeral diaphysis - cementless - 13 (k170452) lot 2105842: 20 items manufactured and released on 07-july-2021.Expiration date: 2026-05-30.No anomalies found related to the problem.To date, 9 items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+6MM
• Common Device Name: SHOULDER LINER
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16291932
• Report Number: 3005180920-2023-00038
• Device Sequence Number: 15135671
• 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: 2022
• Device Explanted Year: 2023
• 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): 02/03/2022

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 Model Number: 04.01.0121
• Device Catalogue Number: 04.01.0121
• Device Lot Number: 2114977
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2022
• 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 Sex: Male