MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P LAT STEM SIZE 7; HIP CEMENTLESS STEM

Model Number	01.18.417
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	05/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2023: lot 2012834: (b)(4).Manufactured and released on 04-may2021.Expiration date: 2026-04-20.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported case during the period of review.Additional devices involved: batch review performed on (b)(6) 2023 versafitcup cc trio 01.26.45.0062 acetabular shell cc trio ø 62 (k103352) lot 150081b: (b)(4)risterilized and released on 10-nov-2020.Expiration date: 2025-11-01.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported case during the period of review.Mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot 2012922: (b)(4).Manufactured and released on 15-apr-2021.Expiration date: 2026-03-28.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with another similar reported case during the period of review.The surgeon reviesed an acetabular liner not marketed in the usa.Clinical evaluation performed by medacta medical affaris manager: the patient had a primary hip surgery on the (b)(6) 2021.On the (b)(6) 2021, the patient came with signs of infection and a washout was performed.Presently, on the (b)(6) 2023, the patient came due to signs of infection and the pathogen is staphylococcus.All the implants have been revised and the surgery was completed successfully.From the radiographic images, signs of infection are visible such as osteolysis localized near the stem.Late infection in cementless tha, almost 2 years 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
The patient had a primary hip surgery on (b)(6) 2021.On the (b)(6) 2021, the patient came with signs of infection and a washout was performed.On the (b)(6) 2023, the patient came due to signs of infection and the pathogen is staphylococcus.All the implants have been revised and the surgery was completed successfully.
Additional Manufacturer Narrative
Additional implant involved, batch review performed on 10-may-2023: liner: mectacer 01.29.415 ceramic liner ø 36 / g (item not distributed in usa) lot.177726 lot.177726: (b)(4) items manufactured and released on 12-mar-2018.Expiration date: 2023-02-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with two other similar reported cases during the period of review.On june 23rd 2023 we have received the items involved in the event.Visual inspection performed by r&d project manager.During the analysis explanted stem, cup, liner and femoral head are evaluated.Some sings and scratches are present on the stem neck part, liner surfaces, head surfaces, cup surfaces reasonably due to revision surgery.Looking at the explanted devices it is not possible to determine the root cause of reported infection.

• Brand Name: AMISTEM-P LAT STEM SIZE 7
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17029867
• Report Number: 3005180920-2023-00390
• Device Sequence Number: 7030269
• Product Code: LZO
• UDI-Device Identifier: 07630040720168
• UDI-Public: 07630040720168
• 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: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2023

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: 04/20/2026
• Device Model Number: 01.18.417
• Device Catalogue Number: 01.18.417
• Device Lot Number: 2012834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2021
• 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: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White