MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM- P SHORT NECK STD STEM SIZE 2; HIP CEMENTLESS STEM

Model Number	01.18.462
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 december 2021: lot 2004641: (b)(4) items manufactured and released on 25-sep-2020.Expiration date: 2025-09-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
During the primary hip surgery, the patient sustained an intraoperative femoral fracture.The surgeon fixed with the 2 cables and expressed an opinion that the event was caused by a technical error.No failure seemed to be observed on device.

• Brand Name: AMISTEM- P SHORT NECK STD STEM SIZE 2
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13356858
• Report Number: 3005180920-2022-00044
• Device Sequence Number: 1778873
• Product Code: LZO
• UDI-Device Identifier: 07630971243668
• UDI-Public: 07630971243668
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K192126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 01/26/2022

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: 09/16/2025
• Device Model Number: 01.18.462
• Device Catalogue Number: 01.18.462
• Device Lot Number: 2004641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2020
• 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: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian