MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+0MM; HUMERAL REVERSE LINER

Model Number 04.01.0119

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 05/22/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 02-jun-2023: lot 1910872: (b)(4) items manufactured and released on 06-mar-2020.Expiration date: 2025-02-22.No anomalies found related to the problem.To date, all items of the same lot have been sold with two other similar reported cases during the period of review.Additional device involved: batch review performed on 02-jun-2023: reverse shoulder system 04.01.0169 glenosphere 36xø24.5 (k170452) lot 1910099: (b)(4) items manufactured and released on 13-may-2020.Expiration date: 2025-05-03.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

The patient came in reporting pain due to a dislocation of the glenosphere from the liner.At about 2 years and 6 months after surgery, the surgeon revised successfully all components.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+0MM
• Type of Device: 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: 17134333
• MDR Text Key: 317220703
• Report Number: 3005180920-2023-00458
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706261
• UDI-Public: 07630040706261
• 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: 06/15/2023

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 Model Number: 04.01.0119
• Device Catalogue Number: 04.01.0119
• Device Lot Number: 1910872
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/06/2020
• 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 Age: 62 YR
• Patient Sex: Male
• Patient Weight: 86 KG