MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM 04.01.0120 HUMERAL REVERSE HC LINER Ø36/+3MM; SHOULDER HUMERAL REVERSE HC LINER

Model Number 04.01.0120

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Implant Pain (4561)

Event Date 11/10/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 22 november 2022: lot 2103236: (b)(4) items manufactured and released on 26-may-2021.Expiration date: 2026-may-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Other devices involved: reverse shoulder system 04.01.0172 glenosphere 36xø27 (k170452) lot 2003999: (b)(4) items manufactured and released on 18-mar-2021.Expiration date: 2026-mar-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot 2003852: (b)(4) items manufactured and released on 01-apr-2021.Expiration date: 2026-mar-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.

Event Description

The patient came in reporting pain due to a bone impingement; the cause is unknown.About 11 months after the primary surgery, the surgeon revised the liner, metaphysis and glenosphere.The surgery was completed successfully.Explants did not show any signs of abnormal wear or damage, and it is not confirmed that there was bone impingement.The doctor thinks there was some bony artifact posterior behind soft tissue creating a fulcrum point.No components were mobilized or malpositioned.

• Brand Name: REVERSE SHOULDER SYSTEM 04.01.0120 HUMERAL REVERSE HC LINER Ø36/+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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15869332
• MDR Text Key: 304353025
• Report Number: 3005180920-2022-00891
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706278
• UDI-Public: 07630040706278
• 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: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.01.0120
• Device Catalogue Number: 04.01.0120
• Device Lot Number: 2103236
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/26/2021
• 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