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
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/07/2024
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 3005180920-2024-00081
• Device Sequence Number: 3306735
• Product Code: PHX
• UDI-Device Identifier: 07630040706018
• UDI-Public: 07630040706018
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2024

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: 04.01.0002
• Device Lot Number: 2242381
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2024
• Supplement Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2022
• 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: Other
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian