MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® MP? CS INSERT SIZE 6 STANDARD 10MM LEFT; KNEE COMPONENT

Model Number	EIS6S10L
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, 7 months post op had increased weight bearing pain.44 months post op- no complaint just visit to doctor but can see some loosening.On (b)(6) 2022 patient was in pain, hyperflex occurred in show due to other issues components have not been revised.This was a prophecy case: (b)(4).
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Additional Manufacturer Narrative
Additional information received on 6/29/2022.This manufacturer report number (b)(4) is considered no longer reportable since it has been indicated that the adverse event was caused by a traumatic event (accident with a scooter that led to a bent/broken tibia base).The incident is related to trauma and not related to a device failure.Please void this report.

• Brand Name: EVOLUTION® MP? CS INSERT SIZE 6 STANDARD 10MM LEFT
• Common Device Name: 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: 14750122
• Report Number: 3010536692-2022-00230
• Device Sequence Number: 2275945
• Product Code: HRY
• UDI-Device Identifier: M684EIS6S10L1
• UDI-Public: M684EIS6S10L1
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K093552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2022

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
• Operator of Device: Other
• Device Model Number: EIS6S10L
• Device Catalogue Number: EIS6S10L
• Device Lot Number: 1639620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/03/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2022
• Supplement Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 06/20/2022
• Supplement Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male