MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® BIOFOAM® CUP; HIP COMPONENT

Model Number 38BF4854

Device Problem Material Disintegration (1177)

Patient Problem Toxicity (2333)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, patient had high cocr levels, the cup was removed without cup cutters.Patient is or was a smoker.

Manufacturer Narrative

See attached.- attachment: [wd011615.Pdf].

• Brand Name: CONSERVE® BIOFOAM® CUP
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9844847
• MDR Text Key: 183873808
• Report Number: 3010536692-2020-00247
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 05/20/2020

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: 38BF4854
• Device Catalogue Number: 38BF4854
• Device Lot Number: 1368264
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/26/2020
• Initial Date Manufacturer Received: 02/26/2020
• Initial Date FDA Received: 03/17/2020
• Supplement Dates Manufacturer Received: 02/26/2020
• Supplement Dates FDA Received: 05/20/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR