MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+0MM; SHOULDER REVERSE SYSTEM HIGH-CROSS LINER

Catalog Number	04.01.0119
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03-aug-2023 lot 2248487: 90 items manufactured and released on 17-apr-2023.Expiration date: 2028-04-01.No anomalies found related to the problem.To date, 53 items of the same lot have been sold with no similar reported event during the period of review.Additional involved implant: batch review performed on 03-aug-2023 on reverse shoulder system 04.01.0207 lat.Glenosphere 36xø24.5 (k193175) lot.2246186 lot 2246186: 40 items manufactured and released on 08-feb-2023.Expiration date: 2028-01-23.No anomalies found related to the problem.To date, 29 items of the same lot have been sold with another similar reported event during the period of review.
Event or Problem Description
The patient had a shoulder hemi-arthroplasty surgery on (b)(6) 2022.On (b)(6) 2023, the patient came in reporting pain after falling and the cause is unknown.The surgeon revised the patient to a reverse shoulder and the surgery was completed successfully.On (b)(6) 2023, the patient came in reporting pain due to a dislocation of the liner from the glenosphere and the cause is unknown.The surgeon revised the metaphysis and liner.The surgery was completed successfully.Presently, on (b)(6) 2023, the patient came in reporting pain due to a dislocation of the liner from the glenosphere and the cause is unknown.The surgeon revised the metaphysis, liner, and glenosphere.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+0MM
• Common Device Name: SHOULDER REVERSE SYSTEM HIGH-CROSS 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: 17489208
• Report Number: 3005180920-2023-00650
• Device Sequence Number: 18110947
• Product Code: PHX
• UDI-Device Identifier: 07630040706261
• UDI-Public: 07630040706261
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 04.01.0119
• Device Lot Number: 2248487
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2023
• Initial Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female