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

Model Number	KIMP310R
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/07/2019
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, during the operation, the washer could not be penetrated.It was repeated it back four more times.After more than 40 minutes, the penetration was still unsuccessful.The patient's bleeding increased.Later, a thicker washer was reopened and the stroke was smooth enter.In surgery the insert cannot be implanted successfully.Although tried for about 40 minutes, it cannot be implanted.The bleeding phenomenon got worse.Surgeon had to change a thicker one and succeeded very easily.

• Brand Name: ADVANCE® II MEDIAL PIVOT TIBIAL INSERT SZ 3 RIGHT
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 13152796
• Report Number: 3010536692-2022-00002
• Device Sequence Number: 11799030
• Product Code: JWH
• UDI-Device Identifier: M684KIMP310R1
• UDI-Public: M684KIMP310R1
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K972770
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2022

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: KIMP310R
• Device Catalogue Number: KIMP310R
• Device Lot Number: 1768059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/15/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 03/02/2022
• 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 Sex: Unknown