MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; ANATOMICAL SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 11

Model Number	04.01.0184
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6)2024.Lot 2240254: (b)(4) items manufactured and released on 12-dec-2022.Expiration date: 2027-11-23.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by clinical affairs department.Revision about 1 year and 2 months after primary tsa, due to stem breaching the cortex.The stem was found to be well fixed.However, in order to alleviate the pain, the surgeon decided to remove all components and converted the patient from a primary to a reverse shoulder with a standard stem.From the post-op primary radiographic image, the stem appears to be in a suboptimal position.We cannot tell if this is the result of post-surgery migration or if it was the position since the conclusion of the primary surgery.Root cause: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.- based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
At about 1 year and 2 months after primary, the patient came in reporting pain due to stem breaching the lateral cortex.The stem was found to be well fixed.However, in order to alleviate the pain, the surgeon removed all the components and converted the patient from a primary to a reverse shoulder.The surgery was completed successfully.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: ANATOMICAL SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 11
• 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: 21157356
• Report Number: 3005180920-2024-01130
• Device Sequence Number: 18250973
• Product Code: KWS
• UDI-Device Identifier: 07630040715928
• UDI-Public: 07630040715928
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180089
• 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): 01/15/2025

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 Model Number: 04.01.0184
• Device Lot Number: 2240254
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2022
• 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: Required Intervention
• Patient Sex: Male