MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CANCELLOUS SELF-TAPPING 6.5MM BONE SCREW 4.0CM LEN; KNEE COMPONENT

Model Number	18080305
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, the patient was revised due to chronic knee pain, loosening of stem and components.(left knee).

• Brand Name: CANCELLOUS SELF-TAPPING 6.5MM BONE SCREW 4.0CM LEN
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11196157
• Report Number: 3010536692-2021-00026
• Device Sequence Number: 703644
• Product Code: HWC
• UDI-Device Identifier: M684180803051
• UDI-Public: M684180803051
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K864626
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1996
• Device Explanted Year: 2006
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/19/2021

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: 18080305
• Device Catalogue Number: 18080305
• Device Lot Number: 043M847240
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/29/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2020
• Initial Report FDA Received Date: 01/19/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR