MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 5; HIP CEMENTLESS STEM

Model Number	01.12.035
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08-feb-2023: lot 2011443: (b)(4) manufactured and released on 22-feb-2021.Expiration date: 2026-02-04.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed by medacta medical manager: revision 1 month after primary tha on a male patient due to joint luxation.The patient had a primary hip surgery after a fall and consequent femoral bone fracture.From the radiographic image provided, the stem seems undersized and subsided which may have caused the adverse event.The surgery was completed successfully revising the medacta stem and head to a competitor stem and head, and revising the medacta cup and liner with a new medacta cup and liner.There is no reason to suspect a faulty device.
Event or Problem Description
On (b)(6) 2022, the patient had a primary hip surgery after a fall and consequent femoral bone fracture.Presently, on (b)(6) 2023, the patient came in reporting a joint luxation.The surgeon noticed that the stem appeared to be undersized and had significant subsidence.The surgery was completed successfully revising the medacta stem and head to a competitor stem and head, and revising the medacta cup and liner with a new medacta cup and liner.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 5
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16435302
• Report Number: 3005180920-2023-00115
• Device Sequence Number: 7401200
• Product Code: JDI
• UDI-Device Identifier: 07630030802171
• UDI-Public: 07630030802171
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2023

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: 02/04/2026
• Device Model Number: 01.12.035
• Device Catalogue Number: 01.12.035
• Device Lot Number: 2011443
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2021
• 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 Sex: Male