MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ANATOMICAL SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 10

Catalog Number 04.01.0183

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/01/2024

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 12 march 2024: lot 2010429: (b)(4) items manufactured and released on 18-jan-2021.Expiration date: 2026-jan-07.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Additional implants involved, batch review performed on 12 march 2024: anatomical shoulder system 04.01.0092 metal humeral head ø44 (k170910) lot 2003857: (b)(4) items manufactured and released on 01-dec-2020.Expiration date: 2025-nov-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Anatomical shoulder system 04.01.0128 hc pegged glenoid ø40 (k170910) lot 2009956: (b)(4) items manufactured and released on 10-feb-2021.Expiration date: 2026-jan-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.

Event Description

Revision surgery was performed at 2 years and 2 months from the primary surgery due to dislocation of the humeral head from the glenoid.Intraoperatively, it was determined that the patient's humerus was fractured and the surgeon opted to use a fracture stem from exactech to complete the case.The surgeon converted the patient from an anatomic shoulder to a reverse shoulder and the surgery was completed successfully.

• Brand Name: ANATOMICAL SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 10
• Type of Device: HUMERAL DIAPHYSIS
• 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: 19018506
• MDR Text Key: 339093168
• Report Number: 3005180920-2024-00167
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040715911
• UDI-Public: 07630040715911
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180089
• 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: 04/02/2024

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: 04.01.0183
• Device Lot Number: 2010429
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/18/2021
• 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 Sex: Female
• Patient Weight: 90 KG
• Patient Race: White