MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 6; HIP CEMENTLESS STEM

Catalog Number 01.12.026

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Inadequate Osseointegration (2646)

Event Date 07/15/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 25-july-2019: lot 168391: (b)(4) items manufactured and released on 26-apr-2017.Expiration date: 2022-04-11.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.

Event Description

Revision surgery after 1 year and 7 months from the primary due to pain caused by a loose stem.The surgeon revised the stem successfully.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 6
• 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: 8877720
• MDR Text Key: 153800424
• Report Number: 3005180920-2019-00667
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802072
• UDI-Public: 07630030802072
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/09/2019

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: 04/11/2022
• Device Catalogue Number: 01.12.026
• Device Lot Number: 168391
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/15/2019
• Initial Date FDA Received: 08/09/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/26/2017
• 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