MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ24.5; SHOULDER GLENOSPHERE

Model Number 04.01.0170

Device Problems Material Rupture (1546); Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem Joint Dislocation (2374)

Event Date 10/08/2021

Event Type  Injury  

Event Description

The patient had primary shoulder surgery on (b)(6) 2021.On (b)(6) 2021, the patient came in reporting pain due to a ruptured subscap and the cause is unknown.The surgeon revised the humeral head, proximal body, glenoid.The surgery was completed successfully.Presently, on (b)(6) 2021, the patient came in reporting pain due to a dislocation of the liner from the glenosphere and the cause of the dislocation is unknown.The surgeon revised the glenosphere and liner and the surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 11 october 2021: lot 2003843a: (b)(4) items manufactured and released on 22-dec-2020.Expiration date: 2025-12-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional device involved: batch review performed on 11 october 2021: reverse shoulder system 04.01.0124 humeral reverse hc liner ø39/+6mm (k170452) lot 2005457: (b)(4) items manufactured and released on 29-july-2020.Expiration date: 2025-07-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ24.5
• Type of Device: 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: 12777447
• MDR Text Key: 280507250
• Report Number: 3005180920-2021-00862
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706575
• UDI-Public: 07630040706575
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/09/2021

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: 04.01.0170
• Device Catalogue Number: 04.01.0170
• Device Lot Number: 2003843A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/22/2020
• 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