MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM 04.01.0122 HUMERAL REVERSE HC LINER Ø39/+0MM; REVERSE HUMERAL LINER

Catalog Number 04.01.0122

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Unspecified Infection (1930)

Event Date 10/31/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 09 novemebr 2023: lot 2008853: (b)(4) items manufactured and released on 18-mar-2021.Expiration date: 2025-11-05.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.Additional component involved (not revised): reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot 2114012: (b)(4) items manufactured and released on 14-feb-2022.Expiration date: 2027-01-31.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0151 glenoid baseplate ø24.5x15 (k170452) lot 2116432: (b)(4) items manufactured and released on 08-mar-2022.Expiration date: 2027-02-22.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 04.01.0162 glenoid polyaxial locking screw - l34 (k170452) lot 2010019: (b)(4) items manufactured and released on 27-nov-2020.Expiration date: 2025-11-16.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 04.01.0162 glenoid polyaxial locking screw - l34 (k170452) lot 2118708: (b)(4) items manufactured and released on 07-feb-2022.Expiration date: 2027-01-24.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 04.01.0170 glenosphere 39xø24.5 lot 2003810b (k170452): (b)(4) items manufactured and released on 11-oct-2021.Expiration date: 2026-09-27.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 had a primary shoulder surgery on (b)(6) 2022.On (b)(6) 2022, the patient came in reporting pain due to falling and dislocating the liner from the glenosphere.The surgeon revised the liner and the surgery was completed successfully.Presently, on (b)(6) the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the liner, metaphysis, baseplate, glenosphere and screws.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM 04.01.0122 HUMERAL REVERSE HC LINER Ø39/+0MM
• Type of Device: REVERSE 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: 18245853
• MDR Text Key: 329478399
• Report Number: 3005180920-2023-00933
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• 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: 2008853
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/18/2021
• 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
• Patient Age: 71 YR
• Patient Sex: Male