MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® MP? CS INSERT SIZE 5 STANDARD 12MM LEFT; KNEE COMPONENT

Model Number EIS5S12L

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Event Description

Allegedly, a patient implanted with mpo components on june 21st has experienced a rash on her skin.The patient has salmonella and she has had three surgeries and cannot get rid of the rash.Therefore, the surgeon is requesting for the metal and plastic composition of the components to determine if the patient is experiencing an allergic reaction to the implant.

• Brand Name: EVOLUTION® MP? CS INSERT SIZE 5 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: 13871861
• MDR Text Key: 287827460
• Report Number: 3010536692-2022-00078
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684EIS5S12L1
• UDI-Public: M684EIS5S12L1
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EIS5S12L
• Device Catalogue Number: EIS5S12L
• Device Lot Number: 1876741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/28/2022
• Date Manufacturer Received: 02/28/2022
• 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 Sex: Female