MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM; SHOULDER HUMERAL REVERSE LINER

Catalog Number 04.01.0122

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Hematoma (1884); Joint Dislocation (2374)

Event Date 10/23/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 03-nov-2023 lot 2306774: (b)(4) items manufactured and released on 13-jul-2023.Expiration date: 2028-06-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Additional component involved: reverse shoulder system 04.01.0170 glenosphere 39xø24.5 (k170452) lot 2103677: (b)(4) items manufactured and released on 12-apr-2021.Expiration date: 2026-03-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.

Event Description

At about 2 weeks after primary, the patient came in reporting pain due to the development of a hematoma that resulted in a dislocation of the joint.The surgeon upsized the poly to give the patient more stability.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM
• Type of Device: SHOULDER HUMERAL REVERSE 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: 18158254
• MDR Text Key: 328351733
• Report Number: 3005180920-2023-00913
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706292
• UDI-Public: 07630040706292
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/17/2023

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: 04.01.0122
• Device Lot Number: 2306774
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/13/2023
• 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