MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA -R CEMENTLESS, HA COATED REVISION STEM SIZE 0; HIP STEM

Catalog Number 01.12.060

Device Problem No Apparent Adverse Event (3189)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/26/2024

Event Type  Injury  

Event Description

The patient had a primary hip surgery on (b)(6) 2021.On (b)(6) 2023, the patient came in reporting pain due to a fractured femur that was caused from falling.The surgeon revised successfully the head and stem.On (b)(6) 2024, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised successfully the head and liner.Presently, on (b)(6) 2024, the patient came in due to a periprosthetic fracture and the case is unknown.The surgeon revised the stem and head.The surgery was completed successfully.

Manufacturer Narrative

Batch review performed on (b)(6) 2024.Lot 2236177: 20 items manufactured and released on 08-feb-2023.Expiration date: 2028-01-23.No anomalies found related to the problem.To date, 4 items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: QUADRA -R CEMENTLESS, HA COATED REVISION STEM SIZE 0
• Type of Device: HIP 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: 19178587
• MDR Text Key: 341000813
• Report Number: 3005180920-2024-00237
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802386
• UDI-Public: 07630030802386
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01.12.060
• Device Lot Number: 2236177
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 111 KG
• Patient Race: White