MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® MP? CS INSERT SIZE 7 STANDARD 14MM LEFT; KNEE COMPONENT

Model Number EIS7S14L

Device Problem Unstable (1667)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Allegedly, patient revised again on (b)(6) 2023 due to instability.Intraoperatively the surgeon discovered poor rotation of the tibial component which didn't show on an x-ray.The surgeon decided to keep the tibia, but revised with a thicker insert and thinner patella.Previous patella total thickness was 34 mm (32 patella /10 mm thick).He took off 18mm with a saw and resurfaced with a 38 mm sized patella (10 mm thick) making the total thickness of the new patella 24 mm.Australia- (b)(4).

Manufacturer Narrative

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

• Brand Name: EVOLUTION® MP? CS INSERT SIZE 7 STANDARD 14MM LEFT
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 17436704
• MDR Text Key: 320163090
• Report Number: 3010536692-2023-00146
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684EIS7S14L1
• UDI-Public: M684EIS7S14L1
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K093552
• 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: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: EIS7S14L
• Device Catalogue Number: EIS7S14L
• Device Lot Number: 1712634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2023
• 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 Age: 61 YR
• Patient Sex: Male