MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION®MP FEM CS/CR POROUS; NO MATCH

Model Number	EFSRP5PR
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, in a tka operation, different sizes of implants were inserted.The femur size 6 non-porous left was contained in the femur size 5 porus right.After the decision of the size was made at the operation, the box of the target implant was double-checked by the doctor and the nurse, and the nurse opened the box and handed it to the doctor, who was about to place the implant in the patient.The patient's femur was cemented, although it was a hybrid, and the operation was successfully completed with no damage to the patient's health.Japan (b)(4).Product inside the box: product id: efsrn6pl evolution®mp fem cs/cr non-por/ lot no: mp2002559/ qty: (b)(4).
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.

• Brand Name: EVOLUTION®MP FEM CS/CR POROUS
• Common Device Name: NO MATCH
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 20561132
• Report Number: 3010536692-2024-00470
• Device Sequence Number: 15702294
• Product Code: MBH
• UDI-Device Identifier: M684EFSRP5PR1
• UDI-Public: M684EFSRP5PR1
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/09/2025

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: EFSRP5PR
• Device Catalogue Number: EFSRP5PR
• Device Lot Number: 2007116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 04/09/2025
• 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 Sex: Unknown