MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø32/+0MM; SHOULDER HUMERAL REVERSE HIGH-CROSS LINER

Model Number	04.01.0116
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting pain and instability and the cause is unknown.About 2 years after the primary surgery, the surgeon revised the patient by converting the reverse shoulder to a hemi-shoulder arthroplasty.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2023.Lot 2008848: (b)(4) items manufactured and released on 10-dec-2020.Expiration date: 2025-nov-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Additional involved implants: batch review performed on (b)(6) 2023 on reverse shoulder system 04.01.0178 glenosphere 32xø24.5 (k170452) lot.183799a lot 183799a: (b)(4) items manufactured and released on 26-jan-2021.Expiration date: 2026-jan-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 during the period of review.Batch review performed on (b)(6) 2023 on reverse shoulder system 04.01.0190 threaded glenoid baseplate ø24.5x25 (k171058 ) lot.1904748 lot 1904748: (b)(4) items manufactured and released on 28-nov-2019.Expiration date: 2024-nov-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Batch review performed on (b)(6) 2023 on reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot.2003795 lot 2003795: (b)(4) items manufactured and released on 10-dec-2020.Expiration date: 2025-nov-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø32/+0MM
• Common Device Name: SHOULDER HUMERAL REVERSE HIGH-CROSS 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16813631
• Report Number: 3005180920-2023-00296
• Device Sequence Number: 17565721
• Product Code: LPH
• UDI-Device Identifier: 07630040706230
• UDI-Public: 07630040706230
• 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: 2021
• 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): 04/26/2023

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: 11/26/2025
• Device Model Number: 04.01.0116
• Device Catalogue Number: 04.01.0116
• Device Lot Number: 2008848
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2020
• 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 Sex: Female