MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM 04.01.0123 HUMERAL REVERSE HC LINER Ø39/+3MM; SHOULDER HUMERAL REVERSE HC LINER

Catalog Number 04.01.0123

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Pain (1994)

Event Date 03/22/2024

Event Type  Injury  

Manufacturer Narrative

Batch review performed on (b)(6) 2024.Lot 2312761: (b)(4) items manufactured and released on 14-aug-2023.Expiration date: 2028-07-25.No anomalies found related to the problem.To date, 35 items of the same lot have been sold with no similar reported event during the period of review.Other devices involved: reverse shoulder system 04.01.0173 glenosphere 39xø27 (k170452) lot 2247043: (b)(4) items manufactured and released on 17-febr-2023.Expiration date: 2028-02-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event during the period of review.

Event Description

The patient had a primary shoulder surgery on (b)(6) 2024.On (b)(6) 2024, the patient came in reporting pain due to a dislocation of the liner from the glenosphere and the cause is unknown.The surgeon revised the liner and the surgery was completed successfully.Presently, on (b)(6) 2024, the patient came in reporting pain due to a dislocation of the liner for the glenosphere.The cause of the dislocation is unknown.The surgeon revised the glenosphere, liner, and metaphysis.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM 04.01.0123 HUMERAL REVERSE HC LINER Ø39/+3MM
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19106325
• MDR Text Key: 340235045
• Report Number: 3005180920-2024-00245
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706308
• UDI-Public: 07630040706308
• 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: 04/15/2024

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 Catalogue Number: 04.01.0123
• Device Lot Number: 2312761
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/14/2023
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Race: White