MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® NITRX? FEM CS/CR; KNEE COMPONENT

Model Number EFSAN2PR

Device Problem Insufficient Information (3190)

Patient Problem Fluid Discharge (2686)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly,the patient (assuming we are talking about a size 2 set of implants) was small framed female.Sales rep is told that exposure was extremely difficult and dr struggled thru the entire case.The cement technique was poor and there was a considerable amount of liquid and fluids present in the wound during application of the cement.The case was a bilateral surgery.He believes both devices required revision in a short period of time following the primary case.It is not confirmed that the devices have been already revised.No part numbers or lot numbers for the devices have been received however, it is indicated that the set of nitrx implants are size number 2.The event regarding the devices implanted on patient's left side are captured under microport orthopedics group number: (b)(4).

Event Description

Allegedly, the patient (assuming we are talking about a size 2 set of implants) was small, framed female.Sales rep is told that exposure was extremely difficult, and dr struggled thru the entire case.The cement technique was poor and there was a considerable amount of liquid and fluids present in the wound during application of the cement.The case was a bilateral surgery.He believes both devices required revision in a short period of time following the primary case.It is not confirmed that the devices have been already revised.No part numbers or lot numbers for the devices have been received however, it is indicated that the set of nitrx implants are size number 2.The event regarding the devices implanted on patient's left side are captured under microport orthopedics group number: (b)(4).Additional information received via phone call on 12/06/2022: it has been indicated that the sales rep is a very experienced great rep and was in the surgery, or surgeries.The patient was a nurse, a small lady that required small implants, size 2.The rep had called mpo?s distributor after the original case.Said the whole surgery was just a fight.Described it as one of the worst cases he had been in.Stated there was blood everywhere, the implants were wet, and all led to bad cement technique.Mpo distributor understanding is the surgeon had put in about 20 nitrx before without any problems, and the surgeon has moved back to another company for implants.Mpo distributor called around to different nitrx users, and none reported any failures with nitrx or cement failures.The likely invoices for these cases have been found.They are both size 2 and are a left and right with the same patient initials, performed about 7 months apart by the surgeon.Mpo distributor believes that both were revised.There is no evidence of any other revisions or issues with the nitrx device outside of this bilateral patient.It does not indicate that the product was revised: product id: kpontp32, advance® onlay all-poly patella 32mm tri-peg, lot: 1884614, qty(b)(4).

• Brand Name: EVOLUTION® NITRX? FEM CS/CR
• Type of Device: KNEE 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: 15905968
• MDR Text Key: 304712112
• Report Number: 3010536692-2022-00433
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: M684EFSAN2PR1
• UDI-Public: M684EFSAN2PR1
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: EFSAN2PR
• Device Catalogue Number: EFSAN2PR
• Device Lot Number: 1873075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/10/2022
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female