MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE II COCR TIBIAL BASE NONPOROUS SZ 2 STANDA; KNEE COMPONENT

Model Number KTCCNP20

Device Problems Loss of Osseointegration (2408); Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 08/24/2020

Event Type  Injury  

Event Description

Allegedly, tibial insert was found to be loose from the tibial base.Patient had her first revision on (b)(6) 2020, it was captured under incident number: (b)(4).

• Brand Name: ADVANCE II COCR TIBIAL BASE NONPOROUS SZ 2 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: 10961831
• MDR Text Key: 220137813
• Report Number: 3010536692-2020-00733
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684KTCCNP201
• UDI-Public: M684KTCCNP201
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960617
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KTCCNP20
• Device Catalogue Number: KTCCNP20
• Device Lot Number: 1652034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR