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

Model Number PHA01202

Device Problem Corroded (1131)

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

Event Date 01/19/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, during revision the head and neck have been removed because were damage, seems to be due to armd wear, so the doctor requested the product removed and requested that be examined closely within the range and for the amount of wear and the degree of discoloration.The doctor will not return the cup and stem.

Event Description

Allegedly, the patient was revised due to a suspected adverse tissue reaction to the implanted products.During revision, the head and neck were removed because of damage that appeared to be implant wear.The physician has requested that the exhibited wear and discoloration of the revised products be analyzed.The acetabular cup and femoral stem will not be returned.Additional information received from (b)(6) on (b)(6) 2021: hospital and physician information.

Manufacturer Narrative

Updated incident description, initial reporter information, adverse event problem and investigation 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: 9758847
• MDR Text Key: 182524317
• Report Number: 3010536692-2020-00162
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012021
• UDI-Public: M684PHA012021
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

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: PHA01202
• Device Catalogue Number: PHA01202
• Device Lot Number: 048583130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/07/2020
• Initial Date Manufacturer Received: 02/07/2020
• Initial Date FDA Received: 02/26/2020
• Supplement Dates Manufacturer Received: 02/07/2020
• Supplement Dates FDA Received: 03/01/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR