MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P COLLARED STD STEM SIZE 6; HIP UNCEMENTED STEM

Catalog Number	01.18.436
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 april 2020: lot 186912: (b)(4) items manufactured and released on 29-oct-2018.Expiration date: 2023-10-18.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 device involved: batch review performed on 28 april 2020: ball heads: mectacer 01.29.208 biolox delta ceramic ball head 12/14 ø 36 size s - 4 (k112115) lot 1810800: (b)(4) items manufactured and released on 06-mar-2019.Expiration date: 2024-01-20.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.Cup: versafitcup cc trio 01.26.45.0058 acetabular shell cc trio ø 58 (k103352) lot 174310: (b)(4) items manufactured and released on 24-oct-2017.Expiration date: 2022-10-15.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.Clinical evaluation performed on the 30 april 2020: delayed infection in cementless tha, 10 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, 10 months after primary surgery, due to an infection at the femoral part ( pathogen agent unknown ).The surgeon removed the whole prosthesis without difficulty.The infection was important so the surgeon decided to not placed new implants and used a spacer instead.

• Brand Name: AMISTEM-P COLLARED STD STEM SIZE 6
• Common Device Name: HIP UNCEMENTED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10073716
• Report Number: 3005180920-2020-00285
• Device Sequence Number: 14165114
• Product Code: LZO
• UDI-Device Identifier: 07630040720250
• UDI-Public: 07630040720250
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2020

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: 10/18/2023
• Device Catalogue Number: 01.18.436
• Device Lot Number: 186912
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 05/20/2020
• 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: 128