MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE I POST STABILIZED TIBIAL INSERT SIZE 3 14; KNEE COMPONENT

Model Number	KIPS0314
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluate.
Event or Problem Description
Allegedly, patient was revised due to infection, the poly was swap.

• Brand Name: ADVANCE I POST STABILIZED TIBIAL INSERT SIZE 3 14
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10042780
• Report Number: 3010536692-2020-00356
• Device Sequence Number: 2464761
• Product Code: HRY
• UDI-Device Identifier: M684KIPS03141
• UDI-Public: M684KIPS03141
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K960617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1997
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2020

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: KIPS0314
• Device Catalogue Number: KIPS0314
• Device Lot Number: A1179731711768
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/27/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2020
• Supplement Report FDA Received Date: 10/27/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 161