MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4; CEMENTLESS STEM

Model Number 01.12.024

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

Patient Problem Inadequate Osseointegration (2646)

Event Date 01/18/2022

Event Type  Injury  

Event Description

Revision surgery performed 4 years and 9 months after the primary surgery due to aseptic loosening of the stem.Head and stem revised.

Manufacturer Narrative

Batch review performed on 17 february 2022.Lot 164543: (b)(4) items manufactured and released on 24-oct-2016.Expiration date: 2021-oct-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4
• 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: 13790632
• MDR Text Key: 287320229
• Report Number: 3005180920-2022-00174
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802058
• UDI-Public: 07630030802058
• 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: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2021
• Device Model Number: 01.12.024
• Device Catalogue Number: 01.12.024
• Device Lot Number: 164543
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/24/2016
• 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
• Patient Age: 48 YR
• Patient Sex: Male