MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY PC SHELL 54MM GROUP E; HIP COMPONENT

Model Number DSPCGE54

Device Problem Malposition of Device (2616)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

The complaint will be updated once the investigation is completed.Trends will be evaluated.

Event Description

Allegedly, patient underwent right thr on (b)(6) 2018, revised on (b)(6) 2019 due to cup malalignment and stem subsidence.Surgeon reported choice of stem size as the cause.The cup was replaced along with a lateralized liner, both competitor's products.The head was also revised with microport's component.

• Brand Name: DYNASTY PC SHELL 54MM GROUP E
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 8660529
• MDR Text Key: 146783365
• Report Number: 3010536692-2019-00803
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: M684DSPCGE541
• UDI-Public: M684DSPCGE541
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K061547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: DSPCGE54
• Device Catalogue Number: DSPCGE54
• Device Lot Number: 1730193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/03/2019
• Date Manufacturer Received: 05/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR