MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA H FEMORAL STEMS; HIP CEMENTLESS STEM

Model Number	01.12.023
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30-dec-2024.Lot 1906968: (b)(4) items manufactured and released on 19-dec-2019.Expiration date: 2024-12-07.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event since the market release.Visual inspection during the analysis, it is evaluated that the stem body is broken close to the distal part.The distal part (tip) of the stem has been cemented into a link megasystem segment to connect the stem to the knee construct.The fractured tip is visible inside the cement of the megasystem segment.Moreover, some signs of damage and scratches are present both on the neck part on the stem and on the body part, but we don't know how these damages occurred.In medacta ifus, it is indicated not to couple medacta implants with competitor implants.This construct is outside the intended use of the device and this is certainly the cause of the reported breakage.The stem was connected to a competitor prosthesis, which is beyond its intended use, subjecting it to unspecified loads that likely led to the breakage.There is no indication that any potential issue with the devices may have caused or contributed to the event.
Event or Problem Description
Primary hip surgery performed on (b)(6) 2020.Revision surgery was performed due to stem fracture about 4 years and a half after the primary surgery.According to the information received, the prosthetic femoral component of the knee was connected to the stem (megaprosthesis with competitor's components) on (b)(6) 2022, and this is the reason for the breakage.

• Brand Name: QUADRA H FEMORAL STEMS
• 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: 21228580
• Report Number: 3005180920-2024-01177
• Device Sequence Number: 12652074
• Product Code: JDI
• UDI-Device Identifier: 07630030802041
• UDI-Public: 07630030802041
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 01/24/2025

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: 12/07/2024
• Device Model Number: 01.12.023
• Device Lot Number: 1906968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2019
• 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: 67 YR
• Patient Sex: Female