MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P LAT SZE 6; FEMORAL CEMENTLESS STEM

Catalog Number	01.18.416
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 march 2021: lot 1908463: (b)(4) items manufactured and released on 06-march-2020.Expiration date: 2025-02-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
3 months after the primary surgery the patient came in with a periprosthetic fracture.The surgeon reported that it was a stress fracture without trauma.The surgeon fixed the fracture successfully.No implants were revised.

• Brand Name: STEM: AMISTEM P LAT SZE 6
• Common Device Name: FEMORAL CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11539593
• Report Number: 3005180920-2021-00200
• Device Sequence Number: 11784011
• Product Code: LZO
• UDI-Device Identifier: 07630040720151
• UDI-Public: 07630040720151
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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): 03/16/2021

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 Expiration Date: 02/23/2025
• Device Catalogue Number: 01.18.416
• Device Lot Number: 1908463
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2021
• Initial Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Weight: 95