MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTIONMP TIB KEELED NONPOR SIZE 4 STANDARD RIG; KNEE COMPONENT

Model Number ETPKN4SR

Device Problems Dull, Blunt (2407); Loss of Osseointegration (2408)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, patient underwent r tkr on (b)(6) 2021.Revised on (b)(6) 2021 due to reported loosening of the tibia.(b)(4).

Manufacturer Narrative

Section h.6 medical device problem code corrected: 2408.

• Brand Name: EVOLUTIONMP TIB KEELED NONPOR SIZE 4 STANDARD RIG
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 12127582
• MDR Text Key: 260443369
• Report Number: 3010536692-2021-00353
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684ETPKN4SR1
• UDI-Public: M684ETPKN4SR1
• Combination Product (y/n): N
• PMA/PMN Number: K093552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/08/2021

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: ETPKN4SR
• Device Catalogue Number: ETPKN4SR
• Device Lot Number: 1858978
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/15/2021
• Initial Date Manufacturer Received: 06/15/2021
• Initial Date FDA Received: 07/07/2021
• Supplement Dates Manufacturer Received: 06/15/2021
• Supplement Dates FDA Received: 09/08/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR