MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® MP? CS INSERT SIZE 6 STANDARD 12MM LEFT; KNEE COMPONENT

Model Number EIS6S12L

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Osteolysis (2377)

Event Date 07/05/2022

Event Type  Injury  

Event Description

Allegedly, complete femoral and tibial bipolar loosening, major osteolysis of the femoral epiphysis and metaphysis preserving the corticals, abundant fibrinous tissue, diffuse deposits of intra-osseous and intra-articular fibrin.Less osteolysis at the tibial level.No issue with the patella.

Manufacturer Narrative

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

• Brand Name: EVOLUTION® MP? CS INSERT SIZE 6 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: 15158915
• MDR Text Key: 297192057
• Report Number: 3010536692-2022-00269
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684EIS6S12L1
• UDI-Public: M684EIS6S12L1
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: EIS6S12L
• Device Catalogue Number: EIS6S12L
• Device Lot Number: 1588773
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/13/2022
• Date Manufacturer Received: 07/13/2022
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Weight: 85 KG