MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® MP? CS INSERT SIZE 8 STANDARD 17MM LEFT; KNEE COMPONENT

Model Number	EIS8S17L
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Insufficient Information (4580)
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 had a second l tkr revision due to instability.Primary case from (b)(6) 2018, revised on (b)(6) 2019 due to instability.10mm insert replaced with 17mm (mpo ref 19030012, ssp ref c750).Patient revised again on (b)(6) 2024 due to instability, the 17mm insert replaced with a 20mm insert.All three cases were performed by (b)(6).Non revised products: product id: kpontp35 advance® onlay all-poly patella 35mm tri-peg/ lot number: 1764903/ qty: 1.Product id: efsrn8pl evolution®mp fem cs/cr non-por size 8 primary left/ lot number: 1637019/ qty: 1.Product id: etpkn8sl evolution®mp tib keeled nonpor size 8 standard left/ lot number: 1586733/ qty: 1.(b)(4).

• Brand Name: EVOLUTION® MP? CS INSERT SIZE 8 STANDARD 17MM LEFT
• Common Device Name: KNEE COMPONENT
• 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: 19742854
• Report Number: 3010536692-2024-00399
• Device Sequence Number: 3616012
• Product Code: HRY
• UDI-Device Identifier: M684EIS8S17L1
• UDI-Public: M684EIS8S17L1
• 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: 2019
• Device Explanted Year: 2024
• 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): 10/01/2024

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: EIS8S17L
• Device Catalogue Number: EIS8S17L
• Device Lot Number: 15512221608237
• 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: 06/19/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male