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
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/18/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3005180920-2022-00190
• Device Sequence Number: 13703080
• Product Code: JDI
• UDI-Device Identifier: 07630030802607
• UDI-Public: 07630030802607
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 03/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White