MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CS INSRT IMPL SZ 5 RIGHT 10MM IMPLANT PARTNERS?; KNEE COMPONENT

Model Number EAI5310RWD

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Event Description

Allegedly, the patient is presenting an allergic reaction on both knees.

Manufacturer Narrative

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

Manufacturer Narrative

Corrected section h.6.Adverse event problem (refer to coding manual) medical device problem code.Void this report as there is no alleged deficiency against the device.

• Brand Name: CS INSRT IMPL SZ 5 RIGHT 10MM IMPLANT PARTNERS?
• 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: 13535390
• MDR Text Key: 285664408
• Report Number: 3010536692-2022-00047
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684EAI5310RWD1
• UDI-Public: M684EAI5310RWD1
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113325
• 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,Followup
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: EAI5310RWD
• Device Catalogue Number: EAI5310RWD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/28/2022
• Date Manufacturer Received: 01/28/2022
• 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