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

Model Number PHA01232

Device Problems Break (1069); Corroded (1131)

Patient Problem Reaction (2414)

Event Date 03/07/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, on (b)(6) 2019 patient was notified that she suffered pseudotumor in her left hip, with concern about friction, corrosion and failure of her profemur modular neck, as well as concern over migration of the dynasty liner.The structural failure of the titanium profemur modular neck components was the result of a fatigue failure of the titanium, caused over time by cyclic loading of the device, resulting in the release of metal paricles within left hip joint.On (b)(6) 2019 patient received a revision surgery and the stem, modular neck and all other components were removed and replaced, the titanium modular neck had corroded and fatigued, and the dynasty liner having migrated.

Manufacturer Narrative

Updated event problem codes.

• Brand Name: PROFEMUR MODULAR FEMORAL NECK
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9844814
• MDR Text Key: 183924536
• Report Number: 3010536692-2020-00246
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012321
• UDI-Public: M684PHA012321
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PHA01232
• Device Catalogue Number: PHA01232
• Device Lot Number: 117485113
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/24/2020
• Date Manufacturer Received: 02/24/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention