MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE® II COCR TIBIAL BASE NONPOROUS SZ 5 STANDA; KNEE COMPONENT

Model Number KTCCNP50

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

Allegedly, patient was revised due to infection.Revision njr number: (b)(4).Side: r.Primary asa: p2 - mild disease not incapacitating.

• Brand Name: ADVANCE® II COCR TIBIAL BASE NONPOROUS SZ 5 STANDA
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 15374627
• MDR Text Key: 299448458
• Report Number: 3010536692-2022-00321
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684KTCCNP501
• UDI-Public: M684KTCCNP501
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K960617
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KTCCNP50
• Device Catalogue Number: KTCCNP50
• Device Lot Number: 1099498231756230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/18/2022
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention