MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM-P COLLARED STD SIZE 2; CEMENTLESS FEMORAL STEM

Model Number	01.18.432
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23-nov-2021: lot 2102788: (b)(4) items manufactured and released on 16-jun-2021.Expiration date: 2026-06-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Clinical evaluation: femoral perforation occurred during cementless stem implantation in an elderly woman ((b)(6) year old).This event may be due to an uforeseen event arisen during femoral preparation in a weakened bone, but we have no information that may enable us to assess the causes of the event.There no reason to suspect a malfunctioning device.
Event or Problem Description
When the amistem-p was inserted, the posterior part of the femur was perforated.After a reinforcement with nespron tape, it was replaced with an amistem-c, but the stem followed the same route and it was not possible to fix it.The cement could not be removed so a second surgery has been performed on (b)(6) with an amis-k.

• Brand Name: STEM: AMISTEM-P COLLARED STD SIZE 2
• Common Device Name: CEMENTLESS FEMORAL 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: 12893674
• Report Number: 3005180920-2021-00938
• Device Sequence Number: 14339543
• Product Code: LZO
• UDI-Device Identifier: 07630040720212
• UDI-Public: 07630040720212
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 11/30/2021

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: 06/07/2026
• Device Model Number: 01.18.432
• Device Catalogue Number: 01.18.432
• Device Lot Number: 2102788
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2021
• 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: Other
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian