MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR MODULAR FEMORAL NECK; HIP COMPONENT

Model Number PHA012XX

Device Problem Corroded (1131)

Patient Problems Tissue Damage (2104); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

This event will be updated when the investigation is complete.

Event Description

Allegedly, the patient was harmed as a result of the product design when it corroded and released metallic debris into the tissue surrounding the implants causing severe tissue damage.Right original surgery 2003 revision (b)(6) 2018.

• Brand Name: PROFEMUR MODULAR FEMORAL NECK
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 9403855
• MDR Text Key: 168876141
• Report Number: 3010536692-2019-01158
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

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: PHA012XX
• Device Catalogue Number: PHA012XX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/04/2019
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 12/03/2019
• Supplement Dates Manufacturer Received: 11/04/2019
• Supplement Dates FDA Received: 08/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention