MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+3MM; SHOULDER LINER

Model Number	04.01.0120
Medical Device Problem Codes	Osseointegration Problem (3003); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	11/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting pain due to a dislocation of the glenosphere from the liner and stem loosening 2 months after the primary surgery.The surgeon revised the liner, metaphysis and diaphysis.
Additional Manufacturer Narrative
Batch review performed on 09-dec-2021.Lot 2004021: (b)(4) items manufactured and released on 23-apr-2021.Expiration date: 2026-apr-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional devices involved: reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot.2003392.Lot 2006591: (b)(4) items manufactured and released on 29-oct-2020.Expiration date: 2025-oct-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Reverse shoulder system 04.01.0182 short humeral diaphysis - cementless - 9 (k180089) lot.1910851.Lot 1910851: (b)(4) items manufactured and released on 12-mar-2020.Expiration date: 2025-mar-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+3MM
• Common Device Name: SHOULDER LINER
• 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: 12983078
• Report Number: 3005180920-2021-00975
• Device Sequence Number: 20148886
• Product Code: PHX
• UDI-Device Identifier: 07630040706278
• UDI-Public: 07630040706278
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 12/13/2021

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: 04/12/2026
• Device Model Number: 04.01.0120
• Device Catalogue Number: 04.01.0120
• Device Lot Number: 2006591
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2021
• 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: Unknown