MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +9MM/0°; SHOULDER METAPHYSIS

Catalog Number 04.01.0111

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 03/12/2024

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 20 march 2024: lot 184050:(b)(4) items manufactured and released on 26-oct-2018.Expiration date: 2023-10-15.No anomalies found related to the problem.Lot 184050a: 17 items have been reworked.No anomalies found related to the problem.Expiration date: 2023-10-15.To date, 16 items of the same lot have been sold with no similar reported event during the period of review.Additional device involved batch review performed on 20 march 2024 reverse shoulder system 04.01.0122 humeral reverse hc liner ø39/+0mm (k170452) lot 2000924: (b)(4) items manufactured and released on 31-march-2020.Expiration date: 2025-03-18.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 04.01.0170 glenosphere 39xø24.5 (k170452) lot 2001140: (b)(4) items manufactured and released on 26-may-2020.Expiration date: 2025-05-13.No anomalies found related to the problem.To date, 54 items of the same lot have been sold with no similar reported event during the period of review.

Event Description

At 3 years and 5 months from the primary, the patient came in reporting instability and the cause is unknown.The surgeon upsized the glenosphere, liner, and metaphysis.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +9MM/0°
• Type of Device: SHOULDER 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: 19059643
• MDR Text Key: 339595086
• Report Number: 3005180920-2024-00206
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706186
• UDI-Public: 07630040706186
• 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: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2023
• Device Catalogue Number: 04.01.0111
• Device Lot Number: 184050A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/26/2018
• 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: Male
• Patient Race: White