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

Catalog Number 04.01.0122

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Joint Laxity (4526)

Event Date 03/19/2024

Event Type  Injury  

Event Description

At about 1 month ater the primary, 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 liner and the surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 11 april 2024: lot 2307537: (b)(4) items manufactured and released on 08-aug-2023.Expiration date: 2028-07-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Additional device involved.Batch review performed on 11 april 2024.Reverse shoulder system 04.01.0170 glenosphere 39xø24.5 (k170452) lot 2317716: (b)(4) items manufactured and released on 05-dec-2023.Expiration date: 2028-11-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

Manufacturer Narrative

Company g1: modified from medacta international to medacta usa.The event happened in the usa.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM
• Type of Device: SHOULDER HUMERAL 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: 19085955
• MDR Text Key: 339877005
• Report Number: 3005180920-2024-00253
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706292
• UDI-Public: 07630040706292
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• 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: 2307537
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/08/2023
• 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: 63 YR
• Patient Sex: Male