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

Model Number 01.12.022

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

Patient Problem Inadequate Osseointegration (2646)

Event Date 09/28/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 02 april 2020: lot 162927: (b)(4) items manufactured and released on 12-aug-2016.Expiration date: 2021-07-18.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.Preliminary investigation performed by r&d hip project manager: preliminary investigation seems to highlight residual ha on the stem and bone residual.However, implants show extensive biological fluids coverage and from the preliminary investigation it is not possible to determine the failure root cause.

Event Description

Revision surgery performed, 19 days after primary surgery, due to stem loosening.The stem, head, and inlay have been explanted.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2
• Type of Device: HIP 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: 10746078
• MDR Text Key: 213384833
• Report Number: 3005180920-2020-00746
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802034
• UDI-Public: 07630030802034
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/28/2020

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: 07/18/2021
• Device Model Number: 01.12.022
• Device Catalogue Number: 01.12.022
• Device Lot Number: 162927
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/28/2020
• Initial Date FDA Received: 10/28/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/12/2016
• 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