MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1, SHORT NECK; 01.12.21SN

Catalog Number 01.12.21SN

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Joint Dislocation (2374)

Event Date 12/01/2017

Event Type  Injury  

Manufacturer Narrative

Batch review performed on (b)(6) 2017.Lot 162966: 85 items manufactured and released on (b)(6) 2016.Expiration date: (b)(6) 2021.No anomalies found related to the problem.To date, 76 items of the same lot have been already sold without any similar reported event.

Event Description

The patient had pain 14 months after primary.During the revision surgery it was noticed that the stem had loosened.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1, SHORT NECK
• Type of Device: 01.12.21SN
• 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, 6874 ; SZ 6874
• MDR Report Key: 7153833
• MDR Text Key: 96007112
• Report Number: 3005180920-2017-00795
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802614
• UDI-Public: 07630030802614
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K082792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2017

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01.12.21SN
• Device Lot Number: 162966
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2017
• Initial Date FDA Received: 12/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2016
• 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