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

Catalog Number	01.18.402
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 april 2021: lot 1910404: (b)(4) items manufactured and released on 16-mar-2020.Expiration date: 2025-03-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional devices involved: batch reviews performed on 09.04.2021: cup: versafitcup cc trio 01.26.45.0048 acetabular shell cc trio ø 48 (k103352) lot 1906905: (b)(4) items manufactured and released on 11-nov-2019.Expiration date: 2024-10-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Ball heads: mectacer 01.29.204 biolox delta ceramic ball head 12/14 ø 32 size s -4 (k112115) lot 1908984: (b)(4) items manufactured and released on 5-feb-2020.Expiration date: 2025-01-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.The liner revised in the complaint is not marketed in the usa.Clinical evaluation performed by medacta medical affairs manager: delayed infection in cementless tha, 9 months after primary operation.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.
Event or Problem Description
Revision surgery performed after 9 months from the primary surgery due to an infection.All implants were revised.

• Brand Name: AMISTEM-P STD STEM SIZE 2
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12438441
• Report Number: 3005180920-2021-00329
• Device Sequence Number: 3779465
• Product Code: LZO
• UDI-Device Identifier: 07630040720014
• UDI-Public: 07630040720014
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 09/08/2021

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: 03/05/2025
• Device Catalogue Number: 01.18.402
• Device Lot Number: 1910404
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 09/08/2021
• 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: 63 YR
• Patient Weight: 80