MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM; SHOULDER LINER

Catalog Number 04.01.0123

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Unspecified Infection (1930)

Event Date 01/31/2024

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 27 february 2024: lot 2100436: (b)(4) items manufactured and released on 25-march-2021.Expiration date: 2026-03-01.No anomalies found related to the problem.To date, (b)(4) 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 27 february 2024: reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot 2003980: (b)(4) items manufactured and released on 06-may-2021.Expiration date: 2026-04-26.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.Reverse shoulder system 04.01.0004 std humeral diaphysis - cementless - 9 (k170452) lot 2006058: (b)(4) items manufactured and released on 15-oct-2020.Expiration date: 2025-10-01.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.Reverse shoulder system 04.01.0155 glenoid baseplate ø27x25 (k170452) lot 2006951: (b)(4) items manufactured and released on 11-nov-2020.Expiration date: 2025-11-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Reverse shoulder system 04.01.0161 glenoid polyaxial locking screw - l30 (k170452) lot 2102243: (b)(4) items manufactured and released on 12-apr-2021.Expiration date: 2026-03-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event during the period of review.Review for reverse shoulder system 04.01.0161 glenoid polyaxial locking screw - l30 (k170452) lot 2106855: (b)(4) items manufactured and released on 13-july-2021.Expiration date: 2026-06-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event during the period of review.Reverse shoulder system 04.01.0173 glenosphere - 39x27 (k170452) lot 2103681: (b)(4) items manufactured and released on 28-apr-2021.Expiration date: 2026-04-13.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.

Event Description

At about 2 years 2 months after the primary, revision surgery on the right side performed due to infection.Explantation of all components and implantation of new shoulder reverse implants.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM
• Type of Device: 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18795926
• MDR Text Key: 336395931
• Report Number: 3005180920-2024-00083
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K170452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.01.0123
• Device Lot Number: 2100436
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female