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

Catalog Number	01.12.147
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 november 2023.Lot 2000333: (b)(4) items manufactured and released on 20-may-2020.Expiration date: 2025-may-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with 1 similar reported event during the period of review.
Event or Problem Description
The surgeon noted radiolucent lines on radiographs 1 year after surgery and diagnosed mild stem loosening on the left hip in zone 1/7/8.The patient does not complain of any pain or discomfort.Revision surgery is not planned.The patient will be monitored.Note: patient is bilateral.
Additional Manufacturer Narrative
Clinical evaluation performed by clinical affairs department on (b)(6) 2024 almost 1 year after a primary tha, using quadra-p implant, stem radiolucencies were noticed by the surgeon during a post-op x-ray check.No clinical information about the patient was reported and no revision surgery is planned.From the available x-rays images, radiolucency lines are appreciable around the proximal femur, in both the ap and lateral views, and also a slightly shortened leg (or perhaps subsidence of the stem secondary to loosening).As the immediate post-op images are unavailable, no comment can be made on the development of the radiolucent lines.This short term outcome is very rare and surprising and we are unable to make a reasonable forecast of the possible evolution.

• Brand Name: STEM: QUADRA-P QUADRA-P LAT STEM SIZE 7
• 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: 18266171
• Report Number: 3005180920-2023-00979
• Device Sequence Number: 3890631
• Product Code: LZO
• UDI-Device Identifier: 07630040720595
• UDI-Public: 07630040720595
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 01/30/2024

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 Expiration Date: 05/18/2025
• Device Catalogue Number: 01.12.147
• Device Lot Number: 2000333
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2023
• Supplement Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2020
• 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
• Patient Weight: 78 KG
• Patient Race: White