MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ANATOMICAL SHOULDER SYSTEM 04.01.0130 HC PEGGED GLENOID Ø44; ANATOMICAL SHOULDER HC PEGGED GLENOID

Model Number	04.01.0130
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 april 2022.Lot 2006586: (b)(4) items manufactured and released on 14-oct-2020.Expiration date: 2025-09-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Other devices involved: batch review performed on 29 april 2022.Anatomical shoulder system 04.01.0092 metal humeral head ø44 (k170910) lot 2001820: (b)(4) items manufactured and released on 28-jul-2020.Expiration date: 2025-07-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Anatomical shoulder system 04.01.0025 humeral anatomical metaphysis - cementless - 135° - 8 (k170910) lot 1905775: (b)(4) items manufactured and released on 28-nov-2019.Expiration date: 2024-11-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Anatomical shoulder system 04.01.0089 double eccenter (k170910) lot 2003801: (b)(4) items manufactured and released on 25-sep-2020.Expiration date: 2025-09-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in reporting pain due to a failed subscapularis muscle and the cause is unknown.The surgeon revised the anatomic head, double eccenter, poly, and anatomic metaphysis 9 months after primary.The surgery was completed successfully.

• Brand Name: ANATOMICAL SHOULDER SYSTEM 04.01.0130 HC PEGGED GLENOID Ø44
• Common Device Name: ANATOMICAL SHOULDER HC PEGGED GLENOID
• 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: 14488699
• Report Number: 3005180920-2022-00398
• Device Sequence Number: 17345815
• Product Code: KWS
• UDI-Device Identifier: 07630040713252
• UDI-Public: 07630040713252
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K170910
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 05/24/2022

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: 09/30/2025
• Device Model Number: 04.01.0130
• Device Catalogue Number: 04.01.0130
• Device Lot Number: 2006586
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2020
• 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