MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0°; SHOULDER HUMERAL REVERSE METAPHYSIS

Catalog Number 04.01.0110

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Implant Pain (4561)

Event Date 10/20/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 16-nov-2023.Lot 2236620: (b)(4) manufactured and released on 25-jan-2023.Expiration date: 2028-01-08.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported case during the period of review.Other devices involved: reverse shoulder system 04.01.0118 humeral reverse hc liner ø32/+6mm (k170452) lot 2203296: (b)(4) manufactured and released on 02-may-2022.Expiration date: 2027-04-18.No anomalies found related to the problem.To date, 6 items of the same lot have been sold with no similar reported case during the period of review.Reverse shoulder system 04.01.0206 lat.Glenosphere 32xø24.5 (k193175) lot 2117710: (b)(4) manufactured and released on 22-mar-2022.Expiration date: 2027-03-07.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported case during the period of review.

Event Description

At about 6 months after primary, the patient came in reporting pain and discomfort and the cause is unknown.The surgeon revised the glenosphere, liner and metaphysis.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0°
• Type of Device: SHOULDER HUMERAL REVERSE METAPHYSIS
• 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: 18158144
• MDR Text Key: 328350400
• Report Number: 3005180920-2023-00898
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706179
• UDI-Public: 07630040706179
• 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: 11/17/2023

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 Catalogue Number: 04.01.0110
• Device Lot Number: 2236620
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/20/2023
• Initial Date FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/25/2023
• 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