MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM P 01.18.401 AMISTEM-P STD STEM SIZE 1; FEMORAL COMPONENT

Model Number	01.18.401
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
At 4 months after primary tha, revision surgery for stem subsidence.The reason of the subsidence is unknown.Stem and head revised successfully.
Additional Manufacturer Narrative
Batch review performed on 22 october 2021: lot 2009269: (b)(4) items manufactured and released on 02-dec-2020.Expiration date: 2025-11-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.

• Brand Name: AMISTEM P 01.18.401 AMISTEM-P STD STEM SIZE 1
• Common Device Name: FEMORAL COMPONENT
• 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: 12826689
• Report Number: 3005180920-2021-00890
• Device Sequence Number: 4265242
• Product Code: LZO
• UDI-Device Identifier: 07630040720007
• UDI-Public: 07630040720007
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/17/2021

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: 11/23/2025
• Device Model Number: 01.18.401
• Device Catalogue Number: 01.18.401
• Device Lot Number: 2009269
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2020
• 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: Other
• Patient Sex: Female