MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 M

Model Number PHA04416

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

This event will be updated when investigation is complete.

Event Description

Allegedly, patient was revised due to unknown.

Manufacturer Narrative

See investigation attached.- attachment: [ripojuly2019signed.Pdf, timingletter19070464.Pdf].

• Brand Name: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 M
• Type of Device: HEAD
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9721126
• MDR Text Key: 180725157
• Report Number: 3010536692-2019-00982
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684PHA044161
• UDI-Public: M684PHA044161
• 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: 02/18/2020

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: PHA04416
• Device Catalogue Number: PHA04416
• Device Lot Number: 048561090
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/02/2019
• Initial Date Manufacturer Received: 07/02/2019
• Initial Date FDA Received: 02/18/2020
• Supplement Dates Manufacturer Received: 07/02/2019
• Supplement Dates FDA Received: 02/18/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR