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

Catalog Number	04.01.0130
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	09/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29-sep-2023.Lot 2103247: 26 items manufactured and released on 30-apr-2021.Expiration date: 2026-04-15.No anomalies found related to the problem.To date, 16 items of the same lot have been sold with no similar reported case during the period of review.
Event or Problem Description
At about 1 year and 1 month after primary, the patient came in reporting pain and the cause was unknown.After reviewing x-rays, the surgeon noticed that the glenoid was not positioned correctly.Particularly, the surgeon commented that he did not put the glenoid in the position that he would have preferred during the primary.The surgeon revised all implants and the surgery was completed successfully.

• Brand Name: ANATOMICAL SHOULDER SYSTEM 04.01.0130 HC PEGGED GLENOID Ø44
• Common Device Name: SHOULDER HC PEGGED GLENOID
• 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: 17956404
• Report Number: 3005180920-2023-00811
• Device Sequence Number: 14776204
• Product Code: KWS
• UDI-Device Identifier: 07630040713252
• UDI-Public: 07630040713252
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170910
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 10/18/2023

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 Expiration Date: 04/15/2026
• Device Catalogue Number: 04.01.0130
• Device Lot Number: 2103247
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2021
• 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 Age: 33 YR
• Patient Sex: Male
• Patient Weight: 118 KG