MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY® A-CLASS® 15DG POLY LINER 36MM GROUP G; HIP COMPONENT

Model Number DLXPLG36

Device Problems Detachment of Device or Device Component (2907); Naturally Worn (2988)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Event Description

Allegedly, an info received from local sales rep that a curious frequency of revisions (two done early 2023, and other two scheduled for next (b)(6) 2023 in two hospitals) of dynasty a-class liners due to high wear rate after 6 to 8 yrs post op.No enough info available regarding the already-done revisions, we will collect info and explants from the scheduled ones.

Manufacturer Narrative

Section b.5: description has been updated/ section d.1: brand name has been updated/ section d.2b.Procode: has been updated/ section d.4: model and lot # has been updated/ section d.6.A and b:implanted date and explanted date has been added/ h.6: medical device problem code has been added.

Event Description

Allegedly, an info received from local sales rep that a curious frequency of revisions (two done early 2023, and other two scheduled for nexton (b)(6) 2023 in two hospitals) of dynasty a-class liners due to high wear rate after 6 to 8 yrs post op.No enough info available regarding the already-done revisions, we will collect info and explants from the scheduled ones.Additional information received on 07/18/2023: allegedly, from my early investigation of the third liner explant, it seemed much more a locking mechanism issue than wear, as the liner does not look thinned out, and the femoral head showed a black mark demonstrating friction against the cup, which might mean that the liner flipped into the cup.

• Brand Name: DYNASTY® A-CLASS® 15DG POLY LINER 36MM GROUP G
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 17249602
• MDR Text Key: 318345426
• Report Number: 3010536692-2023-00131
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2024

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: Other
• Device Model Number: DLXPLG36
• Device Catalogue Number: DLXPLG36
• Device Lot Number: 1535623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2023
• Initial Date FDA Received: 07/03/2023
• Supplement Dates Manufacturer Received: 06/15/2023; 06/15/2023
• Supplement Dates FDA Received: 01/11/2024; 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention