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

Model Number	EIS5P14L
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
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, patient underwent bilateral tkr on (b)(6) 2020.Left knee revised on (b)(6) 2021 due to patient's complaints of instability.Surgeon believes revision was unnecessary but patient insisted.Insert changed from 14mm thickness to 17mm.Previously patient's right knee was revised due to instability in (b)(6) 2020, incident (b)(4).(b)(6)- (b)(4).
Additional Manufacturer Narrative
Updated lot number.

• Brand Name: EVOLUTION MP CS INSERT SIZE 5+ 14MM LEFT
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11496316
• Report Number: 3010536692-2021-00153
• Device Sequence Number: 14439468
• Product Code: HRY
• UDI-Device Identifier: M684EIS5P14L1
• UDI-Public: M684EIS5P14L1
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2021

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: EIS5P14L
• Device Catalogue Number: EIS5P14L
• Device Lot Number: 1649979
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 04/16/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR