MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø32/+6MM; REVERSE SHOULDER LINER

Catalog Number 04.01.0118

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/27/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 3 july 2023: lot: 183527: (b)(4) items manufactured and released on 25-jun-2018.Expiration date: 2023-jun-10.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 device involved: batch review performed on 3 july 2023 reverse shoulder system 04.01.0178 glenosphere 32xø24.5 (k170452) lot: 2117361: (b)(4) items manufactured and released on 22-mar-2022.Expiration date: 2027-mar-02.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 came in reporting pain due to a dislocation of the liner from the glenosphere and the cause was unknown.About 5 months after the primary surgery, the surgeon revised the liner, glenosphere, and metaphysis.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø32/+6MM
• Type of Device: REVERSE SHOULDER 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: 17387717
• MDR Text Key: 319828809
• Report Number: 3005180920-2023-00545
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706254
• UDI-Public: 07630040706254
• 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: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2023
• Device Catalogue Number: 04.01.0118
• Device Lot Number: 183527
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/25/2018
• 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: Female