MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE® II MEDIAL PIVOT TIBIAL INSERT SZ 3 LEFT 1; KNEE COMPONENT

Model Number	KIMP310L
Medical Device Problem Codes	Break (1069); Naturally Worn (2988)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated when investigation is complete.
Event or Problem Description
Allegedly during the revision surgery the surgeon found out that the medial posterior condyle of the primary femur component was broken.The exposed metal part became sharped and dug down into the medial side of the insert.
Additional Manufacturer Narrative
Updated porduct id on section d.Product kftcnp3l previously reported on 3010536692-2019-01002.Kimp310l is a component associated to this event.
Additional Manufacturer Narrative
Updated event and evaluation codes.

• Brand Name: ADVANCE® II MEDIAL PIVOT TIBIAL INSERT SZ 3 LEFT 1
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 8865592
• Report Number: 3010536692-2019-01003
• Device Sequence Number: 2877114
• Product Code: JWH
• UDI-Device Identifier: M684KFTCNP3L1
• UDI-Public: M684KFTCNP3L1
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K972626
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2020

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: Other
• Device Model Number: KIMP310L
• Device Catalogue Number: KIMP310L
• Device Lot Number: 1756314
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/18/2019
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 07/18/2019; 07/18/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 04/17/2020; 05/04/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention