MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. COTYLE; HIP COMPONENT

Model Number PPR6-7260

Device Problem Insufficient Information (3190)

Patient Problem Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly the patient was revised due to lysis socket; lysis stem.Srnjr number: (b)(4).Side: r.Frasa: p1-fit and healthy.

Manufacturer Narrative

The deviced involved is not commercially available in the united states.Therefore the event is not reportable.Please void the initial report.

• Brand Name: COTYLE
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 8115773
• MDR Text Key: 128764680
• Report Number: 3010536692-2018-01494
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PPR6-7260
• Device Catalogue Number: PPR6-7260
• Device Lot Number: S09112474
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/12/2018
• Date Manufacturer Received: 11/29/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR