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

Catalog Number	04.01.0005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	04/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 4 months after the primary, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all components, performed a washout, and reimplanted permanent hardware.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 08 may 2024: lot 2305399: (b)(4) items manufactured and released on 25-may-2023.Expiration date: 2028-05-03.No anomalies found related to the problem.To date, 31 items of the same lot have been sold without any similar reported event during the period of review.Additional implants involved, batch review performed on 08 may 2024: anatomical shoulder system 04.01.0027 humeral anatomical metaphysis - cementless - 135° - 10 (k170910) lot 1901138a: (b)(4) items manufactured and released on 02-dec-2019.Expiration date: 2024-11-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Anatomical shoulder system 04.01.0089 double eccenter (k170910) lot 2307565: (b)(4) items manufactured and released on 16-may-2023.Expiration date: 2028-05-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Anatomical shoulder system 04.01.0095 metal humeral head ø50 (k170910) lot 2304628: (b)(4) items manufactured and released on 25-oct-2023.Expiration date: 2028-10-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Anatomical shoulder system 04.01.0132 hc pegged glenoid ø48 (k170910) lot 2246177: (b)(4) items manufactured and released on 15-may-2023.Expiration date: 2028-04-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: ANATOMICAL SHOULDER SYSTEM STD HUMERAL DIAPHYSIS - CEMENTLESS - 10
• Common Device Name: SHOULDER 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: 19403136
• Report Number: 3005180920-2024-00365
• Device Sequence Number: 6955409
• Product Code: PHX
• UDI-Device Identifier: 07630040706049
• UDI-Public: 07630040706049
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 05/28/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 04.01.0005
• Device Lot Number: 2305399
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2023
• 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