MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: SMS SOLID 01.36.051 SMS SOLID STEM STD SIZE 11; HIP SMS SOLID STEM STD

Catalog Number	01.36.051
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 months after primary, the patient came in reporting pain due to a periprosthetic bone fracture and the cause is unknown.The surgeon revised the medacta stem and head to competitor components and revised the medacta liner with a medacta liner.The surgery was completed successfully.It has been reported a good bone quality.
Additional Manufacturer Narrative
Batch review performed on 08-feb-2024 lot 2108218: (b)(6) items manufactured and released on (b)(6) 2021.Expiration date: 2026-10-19.No anomalies found related to the problem.To date, 25 items of the same lot have been sold with no similar reported case during the period of review clinical evaluation performed by medical affairs department: revision of the stem 1 month and 18 days after tha surgery due to a periprosthetic fracture.According to report the cause is unknown.It may be possible that the patient applied too much force on the leg operated or a quasi-traumatic event took place and because the bone properties were weakened due to the operation the fracture occured.There is no reason to suspect a malfunctioning device.

• Brand Name: STEM: SMS SOLID 01.36.051 SMS SOLID STEM STD SIZE 11
• Common Device Name: HIP SMS SOLID STEM STD
• 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: 18847130
• Report Number: 3005180920-2024-00077
• Device Sequence Number: 7757956
• Product Code: LZO
• UDI-Device Identifier: 07630030888700
• UDI-Public: 07630030888700
• 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: 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): 03/06/2024

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: 01.36.051
• Device Lot Number: 2108218
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2021
• 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: 64 YR
• Patient Sex: Male