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

Catalog Number 01.12.24SN

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Code Available (3191)

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on 03 january 2019: lot 184806: 36 items manufactured and released on 02 october 2018.Expiration date: 2023-09-20.No anomalies found related to the issue.To date, 9 items of the same lot have been already sold without any similar reported event.

Event Description

During the primary hip surgery and after the stem was implanted, the surgeon noticed a foreign substance on the neck of the stem.The surgeon explanted the size 4 quadra h stem and replaced it with another size 4 quadra h stem.This caused a 5 minute delay in the case and the surgery was completed successfully.

Manufacturer Narrative

Visual inspection performed by r&d project manager: visual investigation shows some scratches on the base of the taper cone of the femoral stem and few dot-like scratches on the neck.It is not possible to understand if these are scratches or additional material.Additional information has been requested to the surgeon.Microscopic analysis revealed that there has been a problem during polishing phase and final control.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4, SHORT NECK
• Type of Device: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8217190
• MDR Text Key: 133362934
• Report Number: 3005180920-2018-01060
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030802645
• UDI-Public: 07630030802645
• Combination Product (y/n): N
• PMA/PMN Number: K093944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/20/2023
• Device Catalogue Number: 01.12.24SN
• Device Lot Number: 184806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 01/04/2019
• Supplement Dates Manufacturer Received: 12/06/2018
• Supplement Dates FDA Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other