MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE ONLAY ALL-POLY PATELLA 35MM TRI-PEG; KNEE COMPONENT

Model Number	KPONTP35
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient is experiencing clicking and pain when she lays on her side.No follow up with her doctor yet.Additional information received on 04/22/2020 from reliability engineering: product id and lot information.Additional information received on 10/26/2020 from reliability engineering: updated product id and lot information.

• Brand Name: ADVANCE ONLAY ALL-POLY PATELLA 35MM TRI-PEG
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10748619
• Report Number: 3010536692-2020-00664
• Device Sequence Number: 16563901
• Product Code: JWH
• UDI-Device Identifier: M684KPONTP351
• UDI-Public: M684KPONTP351
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K953439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/28/2020

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: KPONTP35
• Device Catalogue Number: KPONTP35
• Device Lot Number: 1402786
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/26/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 10/28/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention