MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION MP CS INSERT SIZE 5+ 14MM LEFT; KNEE COMPONENT

Model Number EIS5P14L

Device Problem Unstable (1667)

Patient Problems Failure of Implant (1924); Joint Laxity (4526)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, patient underwent bilateral tkr on (b)(6) 2020.Left knee revised on (b)(6) 2021 due to patient's complaints of instability.Surgeon believes revision was unnecessary but patient insisted.Insert changed from 14mm thickness to 17mm.Previously patient's right knee was revised due to instability in (b)(6) 2020, incident (b)(4).(b)(6)- (b)(4).

Manufacturer Narrative

Updated lot number.

• Brand Name: EVOLUTION MP CS INSERT SIZE 5+ 14MM LEFT
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11496316
• MDR Text Key: 246492647
• Report Number: 3010536692-2021-00153
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684EIS5P14L1
• UDI-Public: M684EIS5P14L1
• Combination Product (y/n): N
• PMA/PMN Number: K093552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 04/16/2021

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: EIS5P14L
• Device Catalogue Number: EIS5P14L
• Device Lot Number: 1649979
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/22/2021
• Initial Date Manufacturer Received: 02/22/2021
• Initial Date FDA Received: 03/16/2021
• Supplement Dates Manufacturer Received: 02/22/2021
• Supplement Dates FDA Received: 04/16/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR