MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+0MM; REVERSE SHOULDER LINER

Model Number 04.01.0119

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Joint Dislocation (2374)

Event Date 04/20/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 30 april 2021: lot 173417: (b)(4) items manufactured and released on 27-jun-2017.Expiration date: 2022-06-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with two similar reported events.Additional implant involved: reverse shoulder system glenosphere, unknown reference and lot number.

Event Description

3 years and 1 month after the primary surgery the surgeon reported that the joint luxated (glenosphere from the liner).Therefore he decided to revise the reverse metaphysis (from +0/0 to +9/0) and liner.Glenosphere lot number and reference are unknown and will not be available.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+0MM
• Type of Device: REVERSE SHOULDER LINER
• 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: 11847668
• MDR Text Key: 251641542
• Report Number: 3005180920-2021-00392
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706261
• UDI-Public: 07630040706261
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2022
• Device Model Number: 04.01.0119
• Device Catalogue Number: 04.01.0119
• Device Lot Number: 173417
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/27/2017
• 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