MAUDE Adverse Event Report: EXACTECH, INC ARTHROFOCUS TIBIAL IMPLANT, SIZE 2, 6MM

Catalog Number 256-12-02

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Joint Disorder (2373); No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2016

Event Type  Injury  

Manufacturer Narrative

The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.

Event Description

Revision: reason not reported.Revision of total knee after resurfacing of mono-compartimental.

Manufacturer Narrative

Engineering evaluation noted that the revision reported was likely the result of disease progression, likely osteoarthritis, which required the use of a total knee replacement.

Event Description

Revision: reason not reported.Implanted total knee after resurfacing of mono-compartimental.

Manufacturer Narrative

Implanted approximately 12 years ago.Device evaluation: the scratches and displaced polyethylene appear to be consistent with third body wear.Third body wear occurs when a third body, such as a fragment of bone cement, gets trapped between the polyethylene tibial component and the femoral component.As the patient moves, the third body created scratches,and sometimes pitting on the surface of the polyethylene.All other aspects of the devices appear unremarkable.The revision reported was likely the result of pain disease progression, likely osteoarthritis, which required the use of a total knee replacement.This device is used for treatment not diagnosis.

Event Description

It was reported that a female patient who was initially implanted with a total knee implant approximately 12 years ago complained of pain and radiolucencies were seen on x-ray.A revision implant of the total knee occurred after resurfacing of mono-compartmental was reported.The side of the knee was not reported.This patient has a history of osteonecrosis.This is one of two products involved with the reported event and the associated manufacturer report numbers are 1038671-2016-00868 and 1038671-2016-00870.

• Brand Name: ARTHROFOCUS TIBIAL IMPLANT, SIZE 2, 6MM
• Type of Device: ARTHROFOCUS TIBIAL IMPLANT
• Manufacturer (Section D): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 6180628
• MDR Text Key: 62546351
• Report Number: 1038671-2016-00870
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2016,01/19/2019

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: Physician
• Device Catalogue Number: 256-12-02
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/15/2016
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 12/15/2016
• Initial Date Manufacturer Received: 12/15/2016
• Initial Date FDA Received: 12/16/2016
• Supplement Dates Manufacturer Received: Not provided; 01/18/2019
• Supplement Dates FDA Received: 02/15/2017; 01/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention