MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0; HIP CEMENTLESS STEM

Model Number 01.12.020

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Inadequate Osseointegration (2646)

Event Date 05/17/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 19 may 2021: lot 157411: (b)(4) items manufactured and released on 15-apr-2016.Expiration date: 2021-04-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2017.

Event Description

Primary surgery was performed in 2017, the exact date is not available.Revision surgery was performed on monday, (b)(6) 2021 following stem loosening.Stem, cup, and liner were revised successfully, the surgeon kept the head and sleeve.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0
• 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: 11981364
• MDR Text Key: 255616580
• Report Number: 3005180920-2021-00483
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802010
• UDI-Public: 07630030802010
• 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: 06/11/2021

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: 04/04/2021
• Device Model Number: 01.12.020
• Device Catalogue Number: 01.12.020
• Device Lot Number: 157411
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/12/2021
• Initial Date FDA Received: 06/11/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/15/2016
• 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