MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-P QUADRA-P LAT STEM SIZE 6; CEMENTLESS STEM

Catalog Number	01.12.126
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The surgeon noted radiolucent lines on radiographs 4,5 months after surgery and diagnosed mild stem loosening in zone (b)(6) 2014.The patient does not complain of any pain or discomfort.Revision surgery is not planned.The patient will be monitored.
Additional Manufacturer Narrative
Batch review performed on 22 november 2023: lot 2012808: (b)(4) manufactured and released on 08-apr-2021.Expiration date: 2026-03-17.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event in the period of review.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affair department performed on (b)(6) 2024: four month after a primary tha, using quadra-p implant, stem radiolucencies were noticed by the surgeon during a routine x-ray check.No clinical information about the patient was reported and no revision surgery is planned.From the available x-rays images, radiolucencies lines are appreciable around the proximal femur, in both the ap e lateral views, and also a slightly shortened leg (or perhaps subsidence of the stem secondary to loosening).As the immediate post-op images are not available, no comment can be made as to 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 6
• 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: 18266170
• Report Number: 3005180920-2023-00984
• Device Sequence Number: 14425680
• Product Code: LZO
• UDI-Device Identifier: 07630040720472
• UDI-Public: 07630040720472
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K181254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2024

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: 03/17/2026
• Device Catalogue Number: 01.12.126
• Device Lot Number: 2012808
• 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: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2021
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Race: White