MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® MP? CS INSERT SIZE 4 STANDARD 12MM LEFT; KNEE COMPONENT

Model Number EIS4S12L

Device Problem Unstable (1667)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Allegedly, patient was revised on (b)(6) 2019 due to instability.Sz 4 12mm replaced with sz 4 17mm insert.Surgeon error resulting in instability.Australia c842.

• Brand Name: EVOLUTION® MP? CS INSERT SIZE 4 STANDARD 12MM LEFT
• 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: 9747012
• MDR Text Key: 191241951
• Report Number: 3010536692-2019-01121
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684EIS4S12L1
• UDI-Public: M684EIS4S12L1
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K093552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EIS4S12L
• Device Catalogue Number: EIS4S12L
• Device Lot Number: 1743416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/24/2019
• Date Manufacturer Received: 09/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR