MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM 04.01.0002 STD HUMERAL DIAPHYSIS - CEMENTLESS - 7; SHOULDER HUMERAL DIAPHYSIS CEMENTLESS

Catalog Number 04.01.0002

Device Problem No Apparent Adverse Event (3189)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/07/2024

Event Type  Injury  

Event Description

The patient's humerus fractured during the humeral diaphysis (size 7) insertion.The cement was only in the distal part.A diaphysis (size 6) was used to complete the surgery.

Manufacturer Narrative

Batch review performed on 09-feb-2024.Lot 2242381: (b)(4) items manufactured and released on 06-dec-2022.Expiration date: 2027-11-20.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.

Manufacturer Narrative

On 18 march we have received the device involved in the event.Visual inspection performed by r&d project manager: the diaphysis does not show any signs of damage.No cement residuals are present in the distal part of the diaphysis, while minor remnants are visible on the calcar region.Given the information at hand it is not possible to determine the event root cause.

• Brand Name: REVERSE SHOULDER SYSTEM 04.01.0002 STD HUMERAL DIAPHYSIS - CEMENTLESS - 7
• Type of Device: SHOULDER HUMERAL DIAPHYSIS CEMENTLESS
• 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: 18865036
• MDR Text Key: 337198502
• Report Number: 3005180920-2024-00081
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706018
• UDI-Public: 07630040706018
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.01.0002
• Device Lot Number: 2242381
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2022
• 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): Other
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian