MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE® II COCR TIBIAL BASE NONPOROUS SZ 3+; KNEE COMPONENT

Model Number KTCCNP31

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

Allegedly, patient was revised due to peri-prosthetic fracture revision njr number: (b)(4).Side: r.Primary asa: p2 - mild disease not incapacitating.Component not revised: product: advance ii medial pivot tibia insert sz 3 right 10mm product id: kimp310r lot # : 125303897 qty: 1.

• Brand Name: ADVANCE® II COCR TIBIAL BASE NONPOROUS SZ 3+
• 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: 15169315
• MDR Text Key: 297311480
• Report Number: 3010536692-2022-00273
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684KTCCNP311
• UDI-Public: M684KTCCNP311
• 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,Followup
• Report Date: 08/05/2022

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
• Device Operator: Other
• Device Model Number: KTCCNP31
• Device Catalogue Number: KTCCNP31
• Device Lot Number: 046336330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/15/2022
• Initial Date Manufacturer Received: 07/15/2022
• Initial Date FDA Received: 08/04/2022
• Supplement Dates Manufacturer Received: 07/15/2022
• Supplement Dates FDA Received: 08/05/2022
• 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