MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION MP CS INSERT SIZE 5 STANDARD 14MM LEFT; KNEE COMPONENT

Model Number	EIS5S14L
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to instability.The size 5 14mm tibial insert was removed and replaced with a 24mm thick insert.(b)(4).

• Brand Name: EVOLUTION MP CS INSERT SIZE 5 STANDARD 14MM LEFT
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10268484
• Report Number: 3010536692-2020-00483
• Device Sequence Number: 11612781
• Product Code: HRY
• UDI-Device Identifier: M684EIS5S14L1
• UDI-Public: M684EIS5S14L1
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K093552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2020

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: Health Professional
• Device Model Number: EIS5S14L
• Device Catalogue Number: EIS5S14L
• Device Lot Number: 1672429
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/28/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2020
• Initial Report FDA Received Date: 07/13/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 102