MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE® DOUBLE HIGH TIBIAL INSERT SZ 2 RIGHT 10MM; KNEE COMPONENT

Model Number	KIDH210R
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 underwent r tka on (b)(6) 2011.Revised on (b)(6) 2024 due to instability, 10mm insert replaced with a 14mm insert.Non revised mpo products: product id: kpontp32 advance® onlay all-poly/ lot no.: 0511359918/ qty: 1.Product id: kftcnn3r advance stature® femur/ lot no.: 097473279/ qty: 1.Product id: ktccnp20 advance® ii cocr tibial base/ lot no.: 0411338272/ qty: 1.C24-241 australia.

• Brand Name: ADVANCE® DOUBLE HIGH TIBIAL INSERT SZ 2 RIGHT 10MM
• 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: 19635111
• Report Number: 3010536692-2024-00383
• Device Sequence Number: 8610751
• Product Code: JWH
• UDI-Device Identifier: M684KIDH210R1
• UDI-Public: M684KIDH210R1
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K033890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 10/31/2024

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: KIDH210R
• Device Catalogue Number: KIDH210R
• Device Lot Number: 069882434
• 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: 06/04/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 10/31/2024
• 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 Age: 73 YR
• Patient Sex: Female