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

Catalog Number	01.18.403
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	03/27/2024
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3005180920-2024-00270
• Device Sequence Number: 15311292
• Product Code: LZO
• UDI-Device Identifier: 07630040720021
• UDI-Public: 07630040720021
• 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: 2024
• Device Explanted Year: 2024
• 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): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 01.18.403
• Device Lot Number: 2314337
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2024
• Initial Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2023
• 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 Sex: Unknown