MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+6MM

Catalog Number 04.01.0121

Device Problem Migration (4003)

Patient Problem Joint Dislocation (2374)

Event Date 12/26/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 02 january 2024: lot 2207933: (b)(4) items manufactured and released on 07-jun-2022.Expiration date: 2027-05-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Additional component involved, batch review performed on 02 january 2024:: reverse shoulder system 04.01.0207 lat.Glenosphere 36xø24.5 (k193175) lot.2247045.Lot 2247045: (b)(4) items manufactured and released on 22-feb-2023.Expiration date: 2028-02-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.

Event Description

Revision surgery for shoulder sub-luxation 5 months post primary.Liner, glenosphere and metaphysis revised successfully.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+6MM
• Type of Device: HUMERAL REVERSE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro
• 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: 18517260
• MDR Text Key: 332912783
• Report Number: 3005180920-2023-01113
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706285
• UDI-Public: 07630040706285
• 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: 01/16/2024

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: 04.01.0121
• Device Lot Number: 2207933
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/26/2023
• Initial Date FDA Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/07/2022
• 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