MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM 04.01.0122 HUMERAL REVERSE HC LINER Ø39/+0MM; SHOULDER HUMERAL REVERSE HC LINER

Model Number 04.01.0122

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Implant Pain (4561)

Event Date 11/02/2022

Event Type  Injury  

Event Description

At about 2 years and 2 months after the primary surgery, the patient came in reporting pain.Scapular notching was observed on x-rays.The surgeon performed an arthrotomy with soft tissue/fluid testing for infection and revised the glenosphere, metaphysis and liner.The surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 28-nov-2022: lot 1908971: (b)(4) items manufactured and released on 31-oct-2019.Expiration date: 2024-oct-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed by medical affairs department: revision 2 years and 2 months after the surgery.The patient reported pain.From radiographic images, scapular notching is observed in the distal aspect of the bone.The surgeon performed an arthrotomy with soft tissue/fluid testing for infection and revised the glenosphere which was substituted with a lateralized one, metaphysis and liner.The surgery was completed successfully.Other devices involved: reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot 1908252: (b)(4) items manufactured and released on 12-mar-2020.Expiration date: 2025-mar-01.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported case during the period of review.Reverse shoulder system 04.01.0170 glenosphere 39xø24.5 (k170452) lot 183537: (b)(4) items manufactured and released on 15-oct-2018.Expiration date: 2023-10-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.

• Brand Name: REVERSE SHOULDER SYSTEM 04.01.0122 HUMERAL REVERSE HC LINER Ø39/+0MM
• Type of Device: SHOULDER HUMERAL REVERSE HC 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: 15869313
• MDR Text Key: 304353851
• Report Number: 3005180920-2022-00879
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706292
• UDI-Public: 07630040706292
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.01.0122
• Device Catalogue Number: 04.01.0122
• Device Lot Number: 1908971
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2019
• 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 Sex: Male