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

Catalog Number 01.12.032

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 04/05/2024

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 08-apr-2024.Lot 2106148: (b)(4) items manufactured and released on 09-sep-2021.Expiration date: 2026-08-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Review of the semifinished batch from wich the final implant has been manufactured: the material documentation related to mat32926 has been analyzed and there are no problems of any kind.The material used complies with iso 5832-11 as per design specifications.Clinical evaluation performed by clinical affairs department a cementless tha, performed little more than 2 years ago, incurred in a fracture of the femoral stem.During the time between primary implantation and the fracture, the artifical joint was reoperated 3 times, never removing the femoral stem: the first time was for problems at the surgical wound, and only acetabular insert and modular head were exchanged (standard procedure when the joint is reopened, even though no problem with the implants has arisen), the second time for recurrent dislocation: in this occasion, the cup was exchanged to a double mobility system, to increase stability.However, the wound became infected again, and it was reopened a third time, exchanging again head and insert as per standard procedure.With all these accesses to the joiont, the probability that the neck of the stem got damaged, even in an almost invisible manner, by surgical instruments such as the electrocauter, is extremely high.This is a possible mechanism to create an indentation in the neck that is then likely to be the origin for a fatigue fracture.This patient is heavy (115 kg) and an extra-long head was used: both factors contribute to increase the tensile stress on the neck.No problem for a pristine device, but highly dangerous for a device that has been likely damaged, unwillingly and unnoticed, in the course of the previous revisions.Unfortunately the broken devices have been disposed of and we could not examine them: the origin of the crack is normally visible and identifiable.For this reason, we could only express an estimation of a possible cause for this adverse event.

Event Description

The patient underwent primary surgery on (b)(6) 2022.On (b)(6) 2022, the patient has been revised the first time because of surgical wound issues.Ceramic ball head ø36 size xl and liner ø36/e revised successfully and the surgeon implanted ceramic ball head (ø36 size xl) and pe liner.On (b)(6) 2022, the patient underwent a second revision surgery due to joint luxation.Ball head, liner and acetabular shell have been successfully revised and versafitcup dm ø58mm, liner dm ø28/58mm dmi and cocr ball head ø28 size xl (+7) were implanted.Subsequently to this, on (b)(6) 2022, the patient has been revised because of infection and the surgeon performed a washout with revision of mobile parts of the prosthesis.Presently, on (b)(6) 2024, the patient has been revised for the fourth time because of stem neck breakage.No trauma events reported.No issues detected with the other implants.All components have been revised successfully.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 2
• 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: 19210983
• MDR Text Key: 341353697
• Report Number: 3005180920-2024-00271
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802140
• UDI-Public: 07630030802140
• 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: 04/30/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 01.12.032
• Device Lot Number: 2106148
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/09/2021
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 115 KG