MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2, SHORT NECK; HIP CEMENTLESS STEM

Catalog Number 01.12.22SN

Device Problem Osseointegration Problem (3003)

Patient Problem Inadequate Osseointegration (2646)

Event Date 10/03/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 16-oct-2023: lot 164564: (b)(4) items manufactured and released on 17-oct-2016.Expiration date: 2021-09-21.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed by medical affairs manager on 19 october 2023: revision surgery 6 years and 11 months after primary tha due to stem loosening.From radiographic image, double contour in gruen zones 1 is visible and it suggests that the stem could not find a stable position within the femur.Aseptic loosening is a possible literature described adverse event after primary cementless hip arthroplasties and causes are often unknown.The reason of this failure cannot be determined.

Event Description

Revision surgery at about 6 years and 11 months post-primary due to stem loosening.The stem, head and liner have been revised.No problem were at liner and head level.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2, SHORT NECK
• Type of Device: 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: 18063839
• MDR Text Key: 327240163
• Report Number: 3005180920-2023-00857
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802621
• UDI-Public: 07630030802621
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2021
• Device Catalogue Number: 01.12.22SN
• Device Lot Number: 164564
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/17/2016
• 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