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

Model Number 04.01.0207

Device Problems Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/19/2022

Event Type  Injury  

Event Description

The patient came in reporting instability and looseness and the cause is unknown.At 2 months after the primary surgery, the surgeon revised the lateralized glenosphere, metaphysis, and liner.The surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 20 may 2022.Lot 2110743: (b)(4)items manufactured and released on 19-oct-2021.Expiration date: 2026-oct-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Additional component involved: batch review performed on 20 may 2022.Reverse shoulder system 04.01.0121 humeral reverse hc liner ø36/+6mm (k170452) lot 2103238: (b)(4) items manufactured and released on 28-may-2021.Expiration date: 2026-may-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.

• Brand Name: REVERSE SHOULDER SYSTEM 04.01.0207 LAT. GLENOSPHERE 36XØ24.5
• Type of Device: REVERSE SHOULDER SYSTEM 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: 14733623
• MDR Text Key: 294291954
• Report Number: 3005180920-2022-00465
• 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: 06/17/2022

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: 04.01.0207
• Device Catalogue Number: 04.01.0207
• Device Lot Number: 2110743
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/19/2021
• 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