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
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/06/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8217190
• Report Number: 3005180920-2018-01060
• Device Sequence Number: 16209314
• Product Code: LZO
• UDI-Device Identifier: 07630030802645
• UDI-Public: 07630030802645
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 02/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other