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

Model Number	KIDH210L
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation completed.Evaluation codes added.
Event or Problem Description
Allegedly, patient report pain, poly appeared to be broken upon removal, same size poly was replaced.

• Brand Name: ADVANCE DOUBLE HIGH TIBIAL INSERT SZ 2 LEFT 10MM
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10233608
• Report Number: 3010536692-2020-00467
• Device Sequence Number: 548047
• Product Code: JWH
• UDI-Device Identifier: M684KIDH210L1
• UDI-Public: M684KIDH210L1
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K033890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/06/2020

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: Health Professional
• Device Model Number: KIDH210L
• Device Catalogue Number: KIDH210L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 07/06/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 61 YR