MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+3MM; SHOULDER REVERSE LINER PE

Model Number	04.01.0126
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 may 2022.Lot 2006597: (b)(4) items manufactured and released on 10-dec-2022.Expiration date: 2025-11-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with a similar reported event.Additional component involved: reverse shoulder system 04.01.0209 lat.Glenosphere 42xø24.5 (k193175) lot.2103688: (b)(4) items manufactured and released on 28-may-2021.Expiration date: 2026-05-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.A previous case on the same lot was reported due to joint instability.
Event or Problem Description
The patient had primary shoulder surgery on 7 march 2022.On 6 april 2022, the patient came in reporting instability and the cause is unknown.The surgeon revised the metaphysis and liner.Presently, on 16 may 2022, the patient came in reporting pain due to dislocation and the cause of the dislocation is unknown.The surgeon revised all components except for the stem and the surgery was completed successfully.The surgeon converted the patient to a hemiarthroplasty.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+3MM
• Common Device Name: SHOULDER REVERSE LINER PE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14675294
• Report Number: 3005180920-2022-00447
• Device Sequence Number: 20104780
• Product Code: PHX
• UDI-Device Identifier: 07630040706339
• UDI-Public: 07630040706339
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2022

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: 11/26/2025
• Device Model Number: 04.01.0126
• Device Catalogue Number: 04.01.0126
• Device Lot Number: 2006597
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2022
• 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: Unknown