MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY COCR LINER; HIP COMPONENT

Model Number DLCOGG44

Device Problems Material Disintegration (1177); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Reaction (2414)

Event Type  Injury  

Event Description

Allegedly the patient was revised due to mom complications: pain; high cocr levels (right).Head, sleeve and neck were explanted.Stryker dual mobility was used with our long 28mm ceramic head and a short modular neck (vv8) was implanted.

Manufacturer Narrative

The liner was originally implicated in the mom complications during on (b)(6) 2019 revision but was not revised.The liner was later revised for dislocation on (b)(6) 2019.The investigation was updated to include this information.

• Brand Name: DYNASTY COCR LINER
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 8670676
• MDR Text Key: 147058676
• Report Number: 3010536692-2019-00808
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: DLCOGG44
• Device Catalogue Number: DLCOGG44
• Device Lot Number: 119975128
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/30/2019
• Date Manufacturer Received: 10/14/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR