MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM 04.01.0207 LAT. GLENOSPHERE 36XØ24.5; REVERSE SHOULDER GLENOSPHERE

Model Number 04.01.0207

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 04/11/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 13 april 2022.Lot 2008828a: (b)(4) items manufactured and released on 20-jul-2021.Expiration date: 2026-jul-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Other device involved: batch review performed on 13 april 2022.Reverse shoulder system 04.01.0120 humeral reverse hc liner ø36/+3mm (k170452) lot 2103237: (b)(4) items manufactured and released on 02-jun-2021.Expiration date: 2026-may-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.

Event Description

The patient came in reporting instability and the cause was unknown.At 3 months after the primary surgery, the surgeon revised the glenosphere, liner, and metaphysis.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM 04.01.0207 LAT. GLENOSPHERE 36XØ24.5
• Type of Device: REVERSE SHOULDER GLENOSPHERE
• 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: 14346257
• MDR Text Key: 291304798
• Report Number: 3005180920-2022-00353
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 07630040728065
• UDI-Public: 07630040728065
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.01.0207
• Device Catalogue Number: 04.01.0207
• Device Lot Number: 2008828A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/20/2021
• 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 Sex: Male