MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION®MP FEM CS/CR POROUS SIZE 6 PRIMARY LEFT; KNEE COMPONENT

Model Number	EFSRP6PL
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
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
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 FEM CS/CR POROUS SIZE 6 PRIMARY 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: 14750066
• Report Number: 3010536692-2022-00228
• Device Sequence Number: 16713343
• Product Code: MBH
• UDI-Device Identifier: M684EFSRP6PL1
• UDI-Public: M684EFSRP6PL1
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: EFSRP6PL
• Device Catalogue Number: EFSRP6PL
• Device Lot Number: 1728113
• 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