MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H 01.12.20SN CEMENTLESS, HA COATED STD STEM # 0, SHORT NECK; CEMENTLESS HIP STEM

Model Number 01.12.20SN

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 02/18/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 22 february 2022.Lot 166559: (b)(4) items manufactured and released on 13-feb-2017.Expiration date: 2022-02-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event since 2018.Preliminary investigation performed by r&d project manager: regarding the ceramic head, nothing to say about the cause of the complaint.With regard to the stem, you can see that the hydroxyapatite has been all reabsorbed over the years, but there are no portions/residues of bone within the microstructure.No conclusion can be drawn.

Event Description

The surgeon revised the quadra-h stem and the ceramic head following stem loosening 4 years and 9 months after primary.A new ceramic head and a cemented xacta stem were implanted.

• Brand Name: STEM: QUADRA-H 01.12.20SN CEMENTLESS, HA COATED STD STEM # 0, SHORT NECK
• Type of Device: CEMENTLESS HIP 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: 13826450
• MDR Text Key: 287520543
• Report Number: 3005180920-2022-00190
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802607
• UDI-Public: 07630030802607
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K082792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2022
• Device Model Number: 01.12.20SN
• Device Catalogue Number: 01.12.20SN
• Device Lot Number: 166559
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/13/2017
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White