MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTIONMP TIB KEELED NONPOR; KNEE COMPONENT

Model Number ETPK-N7SL

Device Problems Difficult to Insert (1316); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 02/25/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly the surgeon implanted a size 6lt femur.He implanted a size 7lt tibial base.When asked for the insert the rep noticed that the wrong size tibia was implanted.Should of implanted a size 6+lt tibia base plate.The rep notified the surgeon of the mismatch.By this time the cement had harden.After notifying the family of the options available at the time he decided to put in a 7lt 14mm insert.Additional comments from rep: the surgery time was extended 30 minute beyond the anticipated surgery time due to the surgeon wanting to share with the family what had happened and discuss with them the options and also to decide on how he wanted to proceed.

Event Description

Allegedly, after the surgeon implanted a size 6 left femur, he mistakenly implanted a size 7 left tibial base.When asked for the insert, the sales representative noticed that the wrong size tibia was implanted.He should have implanted a size 6+ left tibia base plate.The sales representative then notified the surgeon of the mismatch.By this time, the cement had hardened.After notifying the family of the options available at the time he decided to put in a size 7 left 14mm insert.Additional comments from distributor: the surgery time was extended 30 minutes beyond the anticipated surgery time due to the surgeon wanting to share with the family what had happened and discuss with them the options and also to decide on how he wanted to proceed.Additional information received on (b)(6) 2020: the patient name was provided.Additional information received on (b)(6) 2021 from (b)(6): adding revision surgeon name and revision date for patient.Allegedly, the patient has since been revised.

Manufacturer Narrative

Additional information was received on (b)(6)2021: stated that the patient has been revised.Updated incident description, patient information, revision surgeon name and revision date for patient.All substantial information from the previous investigation remains valid.No further investigation required.

Event Description

Allegedly, after the surgeon implanted a size 6 left femur, he mistakenly implanted a size 7 left tibial base.When asked for the insert, the sales representative noticed that the wrong size tibia was implanted.He should have implanted a size 6+ left tibia base plate.The sales representative then notified the surgeon of the mismatch.By this time, the cement had hardened.After notifying the family of the options available at the time he decided to put in a size 7 left 14mm insert.Additional comments from distributor: the surgery time was extended 30 minutes beyond the anticipated surgery time due to the surgeon wanting to share with the family what had happened and discuss with them the options and also to decide on how he wanted to proceed.Additional information received on 03/03/2020: the patient name was provided.Additional information received on 01/21/2021 from (b)(6): adding revision surgeon name and revision date for patient.Allegedly, the patient has since been revised.Additional information received on 3/2/2021 from sr.Counsel, litigations: adding description of event occurred on (b)(6) 2019.Allegedly, on (b)(6) 2019 dr.(b)(6) had to re-shave the bone and insert the screws deeper than the initial procedure to improve alignment and stability.The procedure by dr.(b)(6) caused additional impairment and loss of range of motion to the left knee.

Manufacturer Narrative

Updated section b.5.Describe event or problem.

• Brand Name: EVOLUTIONMP TIB KEELED NONPOR
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 8435868
• MDR Text Key: 139306405
• Report Number: 3010536692-2019-00552
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: ETPK-N7SL
• Device Catalogue Number: ETPK-N7SL
• Device Lot Number: 1672691
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/26/2019
• Date Manufacturer Received: 02/26/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR