MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3, SHORT NECK; HIP IMPLANT: CEMENTLESS, HA COATED STEM

Model Number 01.12.23SN

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Hip Fracture (2349)

Event Date 01/24/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 03 february 2020: lot 185839: (b)(4) items manufactured and released on 05-nov-2018.Expiration date: 2023-10-23.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.Clinical evaluation performed by medacta medicla affirs director: fracture with consequent subsidence and stem substitution in a primary cementless tha few days after initial surgery.No reason to suspect a faulty device.Visual inspection performed by medacta r&d department: implant with minimal signs of extraction on the neck, head base and stem.Ha coating fully intact.

Event Description

Revision surgery about 20 days after primary for stem subsidence.The reason is unknown.Fracture at lesser trochanter region detected during revision.The surgeon revised successfully the stem and the ceramic ball head.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3, SHORT NECK
• Type of Device: HIP IMPLANT: CEMENTLESS, HA COATED 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: 9738044
• MDR Text Key: 188738939
• Report Number: 3005180920-2020-00076
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802638
• UDI-Public: 07630030802638
• 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: 02/21/2020

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: 10/23/2023
• Device Model Number: 01.12.23SN
• Device Catalogue Number: 01.12.23SN
• Device Lot Number: 185839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Initial Date Manufacturer Received: 01/22/2020
• Initial Date FDA Received: 02/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2018
• 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 Weight: 103