MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 4; HIP STEM CEMENTLESS

Model Number	01.18.414
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	05/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed due to subsided stem, at about 1 year after the primary.The patient reported pain and the x-rays revealed that the stem was undersized.The surgeon revised also the cup that appeared loosened.
Additional Manufacturer Narrative
Batch review performed on 02 june 2023.Lot 2103860: (b)(4) items manufactured and released on 09-june-2021.Expiration date: 2026-05-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Additional device involved in the event: cup: versafitcup cc trio 01.26.45.0058 acetabular shell cc trio ø 58 (k103352) lot.2109131: 100 items manufactured and released on 13-oct-2021.Expiration date: 2026-09-29.No anomalies found related to the problem.To date, 91 items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation: revision surgery 1 year after the cementless hip surgery due to subsided stem.According to report and from the radiographic images provided, the stem seems undersized.The surgeon revised also the cup that appeared not integrated.There is no reason to suspect a malfunctioning device.
Additional Manufacturer Narrative
Clinical evaluation (corrected) revision surgery 1 year and 2 months after the cementless hip surgery due to subsided stem.According to report and from the radiographic images provided, the stem seems undersized.The surgeon revised also the cup that appeared not integrated.There is no reason to suspect a malfunctioning device.Reason for the follow-up: incorrect date of event reported: (b)(6) 2023 is the correct one ((b)(6) 2023 was reported) date of explant corrected in (b)(6) 2023 ((b)(6) 2023 was reported) event description corrected (because the delta time is different) clinical with delta time corrected.
Event or Problem Description
Revision surgery performed due to subsided stem, at about 1 year and 2 months after the primary.The patient reported pain and the x-rays revealed that the stem was undersized.The surgeon revised also the cup that appeared loosened.

• Brand Name: STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 4
• Common Device Name: HIP STEM CEMENTLESS
• 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: 17181541
• Report Number: 3005180920-2023-00477
• Device Sequence Number: 6495860
• Product Code: LZO
• UDI-Device Identifier: 07630040720137
• UDI-Public: 07630040720137
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2023

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: 05/27/2026
• Device Model Number: 01.18.414
• Device Catalogue Number: 01.18.414
• Device Lot Number: 2103860
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2021
• 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: 59 YR
• Patient Sex: Male