MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P STD STEM SIZE 3; CEMENTLESS STEM

Catalog Number 01.18.403

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Joint Laxity (4526)

Event Date 03/27/2024

Event Type  Injury  

Event Description

At 6 days after primary, revision surgery due to periprosthetic fracture.The surgeon revised all components successfully.The cup was also revised because the surgeon preferred to go for a safetiest way and converted to double mobility rather than a ceramic cup to ensure stability and safety.

Manufacturer Narrative

Batch review performed on (b)(6) 2024.Lot 2314337: 30 items manufactured and released on 18-oct-2023.Expiration date: 2028-09-27.No anomalies found related to the problem.To date, 20 items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affairs department: revision 6 days after tha due to periprosthetic fracture.The surgeon decided for a safer choice and he revised also the cup converting it to double mobility rather than a ceramic cup to improve stability and safety.From the radiographic image, the fracture is visible, there is no specific mention of traumatic event and of course is also possible that the initial crack was created intraoperatively, perhaps during broaching.Intraoperative femoral fractures are known possible adverse events of total hip replacements, described and quantified in literature.They mainly depend on bone morphology and mechanical properties.In this case, there is no reason to suspect a malfunctioning device.

• Brand Name: STEM: AMISTEM P AMISTEM-P STD STEM SIZE 3
• Type of Device: 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: 19178903
• MDR Text Key: 341000762
• Report Number: 3005180920-2024-00270
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630040720021
• UDI-Public: 07630040720021
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K173794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/25/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 01.18.403
• Device Lot Number: 2314337
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention