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

Model Number 01.12.025

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Inadequate Osseointegration (2646)

Event Date 07/13/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 23 july 2021: lot 083652: (b)(4) items manufactured and released on 05-feb-2009.Expiration date: 31/12/2013.No anomalies found related to the problem.To date, all items of the same lot have been sold.No other similar events have been reported on this lot since 2017.Clinical evaluation performed by medical affairs manager: hip revision surgery performed 12 years after cementless tha in (b)(6) year old man.Radiologic image provided shows the presence of bone alterations that can be ascribed to an infection.Infection is a known possible adverse event following every surgery, including tha's and can be hardly related to implant.Preliminary investigation performed by project manager: looking at the picture received with the complaint is possible to see the hydroxyapatite has been totally reabsorbed as expected.No definitive root cause can be defined.

Event Description

Revision surgery performed 12 years 2 months after the primary due to stem loosening with supposed infection.The surgeon decided to remove all the implants and implant a new hip.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5
• Type of Device: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 12223761
• MDR Text Key: 263375445
• Report Number: 3005180920-2021-00645
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802065
• UDI-Public: 07630030802065
• 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: 07/26/2021

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 Expiration Date: 12/31/2013
• Device Model Number: 01.12.025
• Device Catalogue Number: 01.12.025
• Device Lot Number: 083652
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/13/2021
• Initial Date FDA Received: 07/26/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/05/2009
• 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: 83 YR
• Patient Weight: 46