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

Model Number	PHA01232
Medical Device Problem Codes	Break (1069); Corroded (1131)
Health Effect - Clinical Code	Reaction (2414)
Date of Event	03/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem 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.
Additional Manufacturer Narrative
Updated event problem codes.

• Brand Name: PROFEMUR MODULAR FEMORAL NECK
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9844814
• Report Number: 3010536692-2020-00246
• Device Sequence Number: 19547064
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012321
• UDI-Public: M684PHA012321
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 10/05/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention