MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CUSTOM PELVIS LEFT; HIP COMPONENT

Model Number CP7A0919

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 05/05/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, patient was revised due to infection.The cement, constrained liner and ceramic head were remove.They washed everything as completely as possible then cement in a new constrained liner and head then plastics were covered.

Manufacturer Narrative

Void record, the component is not commercially available by mpo.

• Brand Name: CUSTOM PELVIS LEFT
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10085671
• MDR Text Key: 191965085
• Report Number: 3010536692-2020-00377
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/04/2020

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: CP7A0919
• Device Catalogue Number: CP7A0919
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/06/2020
• Initial Date Manufacturer Received: 05/06/2020
• Initial Date FDA Received: 05/25/2020
• Supplement Dates Manufacturer Received: 05/06/2020
• Supplement Dates FDA Received: 09/04/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR