MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5; HIP STEM CEMENTLESS

Model Number 01.12.025

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Osteolysis (2377)

Event Date 08/08/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 09 august 2022: lot 083527: (b)(4) items manufactured and released on 20-jan-2009.Expiration date: 2013-12-31.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event during the period of review.

Event Description

Revision surgery at about 12 years and 11 months for femur osteolysis.The surgeon revised the stem head and liner successfully.

Manufacturer Narrative

This follow up has been sent to enter the device manufacturer date, since by human error it had not been put in the initial report.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5
• Type of Device: HIP STEM CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15370485
• MDR Text Key: 299377678
• Report Number: 3005180920-2022-00670
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802065
• UDI-Public: 07630030802065
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 09/09/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2013
• Device Model Number: 01.12.025
• Device Catalogue Number: 01.12.025
• Device Lot Number: 083527
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/08/2022
• Initial Date FDA Received: 09/07/2022
• Supplement Dates Manufacturer Received: 08/08/2022
• Supplement Dates FDA Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/20/2009
• 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 Sex: Male