MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: SMS SOLID SMS SOLID STEM STD SIZE 6; HIP NON CEMENTED STEM

Model Number	01.36.046
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 7 days after the primary, the patient came in reporting pain due to a periprosthetic fracture and the cause is unknown.The surgeon cabled the fracture and revised the stem and head.The surgery was completed successfully.Patient's poor bone quality.
Additional Manufacturer Narrative
Batch review performed on 14 april 2023.Lot 2114511: (b)(4) items manufactured and released on 09-march-2022.Expiration date: 2027-02-24.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: STEM: SMS SOLID SMS SOLID STEM STD SIZE 6
• Common Device Name: HIP NON CEMENTED STEM
• 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: 16874675
• Report Number: 3005180920-2023-00326
• Device Sequence Number: 17599900
• Product Code: LZO
• UDI-Device Identifier: 07630030888656
• UDI-Public: 07630030888656
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 05/05/2023

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: 01.36.046
• Device Catalogue Number: 01.36.046
• Device Lot Number: 2114511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2022
• 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 Age: 67 YR
• Patient Sex: Male
• Patient Race: Black Or African American