MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM 04.01.0121 HUMERAL REVERSE HC LINER Ø36/+6MM; SHOULDER HUMERAL REVERSE HC LINER

Model Number	04.01.0121
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17-oct-2022 lot 179118: (b)(4).Expiration date: 2023-mar-07.No anomalies found related to the problem.(b)(4).Other device involved: batch review performed on 10-nov-2022.Reverse shoulder system 04.01.0207 lat.Glenosphere 36xø24.5 (k193175) lot 2008828a: (b)(4).Expiration date: 2026-07-08.No anomalies found related to the problem.(b)(4).
Event or Problem Description
At about 2 months after the primary surgery, the patient came in reporting pain due to a dislocation and the cause of the dislocation is unknown.The surgeon revised the metaphysis and liner and the surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM 04.01.0121 HUMERAL REVERSE HC LINER Ø36/+6MM
• Common Device Name: SHOULDER HUMERAL REVERSE HC 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15770502
• Report Number: 3005180920-2022-00830
• Device Sequence Number: 14685545
• Product Code: PHX
• UDI-Device Identifier: 07630040706285
• UDI-Public: 07630040706285
• 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: 2022
• Device Explanted Year: 2022
• 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): 11/10/2022

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 Expiration Date: 03/07/2023
• Device Model Number: 04.01.0121
• Device Catalogue Number: 04.01.0121
• Device Lot Number: 179118
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2018
• 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: Male