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

Model Number PHA01202

Device Problems Corroded (1131); Material Discolored (1170)

Patient Problem Reaction to Medicinal Component of Device (4574)

Event Date 09/01/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, due to doubt of armd (adverse reaction to metal debris) which is a revision because it is a pseudotumor after total hip arthroplasty.The surgeon, dr.(b)(6), mentioned that this can occur with metal on metal devices.The surgeon requested to measure the amount of implant wear at the following junctions: cup + head, head + neck, and neck + stem.The interface between the femoral head and the neck and the interface between the stem and neck have black discoloration.The articulating surface of the femoral head and cup visually looks good.(b)(4).

Manufacturer Narrative

Updated incident description, initial reporter information and investigation codes.

Event Description

Allegedly, the patient was revised due to a suspected adverse tissue reaction to metal debris (armd) and the presence of a pseudotumor.The surgeon indicated that such complications can occur with metal-on-metal (mom) tha constructs and has requested to assess the wear of the products at the following junctions: acetabular cup and femoral head, femoral head and femoral neck, and femoral neck and femoral stem.The surgeon describes the presence of "black discoloration" at the interfaces between the femoral head and the femoral neck as well as between the femoral neck and femoral stem.Additionally, the surgeon described the articulating surfaces of the femoral head and acetabular cup as "visually looks good." japan- (b)(4).

• 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: 10602946
• MDR Text Key: 209118256
• Report Number: 3010536692-2020-00635
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

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: 019791349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/09/2020
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 09/29/2020
• Supplement Dates Manufacturer Received: 09/09/2020
• Supplement Dates FDA Received: 02/26/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 100