MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE® II MEDIAL PIVOT TIBIAL INSERT SZ 4 LEFT 1; KNEE COMPONENT

Model Number	KIMP410L
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to infection.Revision njr number: 5053733.Side: l.Primary asa: p2 - mild disease not incapacitating.Products not revised: product id: lot number: qty: kftcnn4l 29818984 1.Ktccnp41 111294968 1.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.

• Brand Name: ADVANCE® II MEDIAL PIVOT TIBIAL INSERT SZ 4 LEFT 1
• 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: 16725530
• Report Number: 3010536692-2023-00062
• Device Sequence Number: 17944388
• Product Code: JWH
• UDI-Device Identifier: M684KIMP410L1
• UDI-Public: M684KIMP410L1
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K972770
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 06/02/2023

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: KIMP410L
• Device Catalogue Number: KIMP410L
• Device Lot Number: 801202027
• 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: 03/22/2023
• Supplement Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 06/02/2023
• 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