MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: SMS SOLID STEM LAT SIZE 5; STEM SOLID CEMENTLESS

Catalog Number	01.36.065
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 4 months after the primary, revision surgery due to periprosthetic fracture.Implants successfully revised.
Additional Manufacturer Narrative
Batch review performed on 31 july 2024 lot 2244052: (b)(4) items manufactured and released on 22-march-2023.Expiration date: 2028-03-01.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.Clinical evaluation performed by medical affairs department revision 4 months after the primary, due to periprosthetic fracture.No information regaring a traumatic event was given.The fractures close to the surgery mainly depend on bone morphology and mechanical properties.With the information at hand it is not possible to determine the cause of the event.

• Brand Name: STEM: SMS SOLID STEM LAT SIZE 5
• Common Device Name: STEM SOLID 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: 19936768
• Report Number: 3005180920-2024-00654
• Device Sequence Number: 17365974
• Product Code: LZO
• UDI-Device Identifier: 07630030888779
• UDI-Public: 07630030888779
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K181693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2024

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: 01.36.065
• Device Lot Number: 2244052
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2023
• 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: 84 YR
• Patient Sex: Male
• Patient Weight: 94 KG
• Patient Race: White