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

Device Problem Malposition of Device (2616)

Patient Problem Implant Pain (4561)

Event Date 09/11/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 325907439
• Report Number: 3005180920-2023-00811
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 07630040713252
• UDI-Public: 07630040713252
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170910
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 04.01.0130
• Device Lot Number: 2103247
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/18/2023
• Initial Date FDA Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Sex: Male
• Patient Weight: 118 KG