MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR NECK NEUTRAL LONG COBALT CHROME; HIP COMPONENT

Model Number PHAC1204

Device Problem Insufficient Information (3190)

Patient Problems Reaction (2414); Metal Related Pathology (4530)

Event Type  Injury  

Manufacturer Narrative

This event will be updated when investigation is complete.

Event Description

Allegedly the patient was revised due to mom complications.Left hip.

Manufacturer Narrative

Updated section b5, e1, f and h6.Correction on aware date, incident description and initial reporter.Updated event and evaluation codes.

Event Description

Allegedly the patient was revised due to mom complications: high cocr ion levels.Left hip.

• Brand Name: PROFEMUR NECK NEUTRAL LONG COBALT CHROME
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9150827
• MDR Text Key: 161670579
• Report Number: 3010536692-2019-01071
• Device Sequence Number: 1
• Product Code: JDL
• UDI-Device Identifier: M684PHAC12041
• UDI-Public: M684PHAC12041
• Combination Product (y/n): N
• PMA/PMN Number: K091423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PHAC1204
• Device Catalogue Number: PHAC1204
• Device Lot Number: 08977193001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/29/2019
• Date Manufacturer Received: 08/29/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR