MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 39/+0MM; SHUOLDER REVERSE LINER

Model Number 04.01.0122

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Infection (4544)

Event Date 12/15/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 21 december 2020: lot 1908971: (b)(4) items manufactured and released on 31-oct-2019.Expiration date: 2024-10-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional device involved: reverse shoulder system 04.01.0173 glenosphere 39xø27 (k170452) lot 2001142: (b)(4) items manufactured and released on 17-jun-2020.Expiration date: 2025-06-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.

Event Description

Potentially infected event, suppurated wound 2 months after primary.During the surgery, the surgeon realized that the image of liquid that was seen in the resonance was only a collection of non-purulent exudate.After a thorough cleaning, however, he decided to replace glenosphere and liner with items of the same size and to wash abundantly with disinfectants.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 39/+0MM
• Type of Device: SHUOLDER REVERSE 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: 11154583
• MDR Text Key: 226263608
• Report Number: 3005180920-2021-00036
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706292
• UDI-Public: 07630040706292
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 01/12/2020

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
• 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
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 01/12/2021
• 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 Age: 72 YR
• Patient Weight: 85