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

Model Number DSBFGE54

Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

This event was reported under: 3010536692-2019-00766 and 3010536692-2019-00768.

Event Description

Allegedly the patient underwent right thr on (b)(6) 2019, revised on (b)(6) 2019 due to cup mal-positioning.The patient dislocated three times following primary surgery.During revision the same cup was repositioned, flat liner replaced with hooded liner, longer head was used and a screw added.Both procedures were performed through posterior approach.

• Brand Name: DYNASTY® BF 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: 9940921
• MDR Text Key: 187509490
• Report Number: 3010536692-2019-00918
• Device Sequence Number: 1
• Product Code: JDL
• UDI-Device Identifier: M684DSBFGE541
• UDI-Public: M684DSBFGE541
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K082924
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DSBFGE54
• Device Catalogue Number: DSBFGE54
• Device Lot Number: 1777439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/13/2019
• Date Manufacturer Received: 05/13/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention