MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY® DUAL MOBILITY LINER; HIP COMPONENT

Model Number DLDMGC38

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/17/2021

Event Type  Injury  

Event Description

Allegedly, item implanted on (b)(6) 2021 without incident, patient presented at emergency room on (b)(6) 2021 with dislocation of head/liner construct form shell/liner.Closed reduction was attempted and unsuccessful.Patient was referred to (b)(6).Revising surgeon decided removal of all implants was in best interest of patient.Components successfully explanted on (b)(6) 2021.A sales representative was present at the process.Patient suffering from dementia and non-ambulatory.

Manufacturer Narrative

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

• Brand Name: DYNASTY® DUAL MOBILITY LINER
• 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: 13111951
• MDR Text Key: 286513915
• Report Number: 3010536692-2021-00606
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: M684DLDMGC381
• UDI-Public: M684DLDMGC381
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2022

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: DLDMGC38
• Device Catalogue Number: DLDMGC38
• Device Lot Number: 1876268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/02/2021
• Initial Date Manufacturer Received: 12/02/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 12/02/2021
• Supplement Dates FDA Received: 02/16/2022
• 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
• Patient Age: 89 YR
• Patient Sex: Female