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

Catalog Number 04.01.0110

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Unspecified Infection (1930)

Event Date 03/08/2024

Event Type  Injury  

Event Description

At about 3 weeks from the primary, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all components and implanted an antibiotic spacer.The surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 14 march 2024 lot 2318843a: (b)(4) items manufactured and released on 05-dec-2023.Expiration date: 2028-11-16.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.Other devices involved in the event, batch review performed on 14 march 2024.Reverse shoulder system 04.01.0120 humeral reverse hc liner ø36/+3mm (k170452) lot.2305694 lot 2305694: (b)(4) items manufactured and released on 09-aug-2023.Expiration date: 2028-07-17.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 04.01.0157 glenoid polyaxial locking screw - l14 (k170452) lot.2116353a lot 2116353a: (b)(4) items manufactured and released on 08-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 04.01.0157 glenoid polyaxial locking screw - l14 (k170452) lot.2240564 lot 2240564: (b)(4) items manufactured and released on 25-nov-2022.Expiration date: 2027-11-09.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 04.01.0157 glenoid polyaxial locking screw - l14 (k170452) lot.2335881 lot 2335881: (b)(4) items manufactured and released on 24-oct-2023.Expiration date: 2028-09-30.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 04.01.0182 short humeral diaphysis - cementless - 9 (k180089) lot.2244678 lot 2244678: (b)(4) items manufactured and released on 25-jan-2023.Expiration date: 2028-01-03.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 04.01.0207 lat.Glenosphere 36xø24.5 (k193175) lot.2307390 lot 2307390: (b)(4) items manufactured and released on 24-may-2023.Expiration date: 2028-05-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0401 grs baseplate - ø24.5x20 - full wedge 15° (k231911) lot.2307089 lot 2307089: (b)(4) items manufactured and released on 22-nov-2023.Expiration date: 2028-11-04.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.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0°
• Type of Device: 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: 19042188
• MDR Text Key: 339435373
• Report Number: 3005180920-2024-00182
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/04/2024

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: 2318843A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/05/2023
• 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
• Patient Sex: Female