MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; TIBIAL PLATE FB SZ 3 LT

Catalog Number 350-11-03

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 11/01/2019

Event Type  malfunction  

Event Description

It was reported from the vantage total ankle study, that a patient experienced possible loosening noted at 2-year follow up x-ray.Action taken: medication.The case report form indicates this event is possibly related to the devices and related to the procedure.The patient is also suffering pain along posterior tibial tendon.No additional information is available.

Manufacturer Narrative

As a result of an fda inspection conducted in jan 2020, exactech, (b)(4), has committed to remediating 3 years of complaints (2017-2020).This mdr is being submitted as part of that remediation.Device remains implanted.Eng eval completed on 2020.03.24 by (b)(4).Design-related issues: the design of the vantage ankle has been in the field since 2015.Since 2015, exactech has received (b)(4) complaint reports ankle components due to loosening.Sales data for all tibial ankle components was used to calculate an approximate complaint occurrence rate of considered "very low" according to the frequency of occurrence ranking scale detailed below.Therefore, this issue does not appear to be design related.(b)(4).Exactech is not aware of any complaints involving parts from these manufacturing lots, which have been in the field since 2017.The manufacturing records for this device only exist in paper form and are stored in cardboard boxes at (b)(4).Due to risks associated with covid-19 transmission, the physical manufacturing records for this complaint will not be reviewed.Exactech will continue to monitor this complaint type and, if warranted, will escalate any positive trends to the corrections and removal committee (crc) for additional actions.Corrective actions are not required because loosening is listed in the product labeling, the occurrence rate is "very low", and the risk is captured in the rmr.The loosening reported in experience (b)(4) was likely the result of an insufficient bond between the implant and the bone, which led to possible aseptic (non-infected) loosening.However, this cannot be confirmed as the patient has not been revised.Properly functioning implants depend on their appropriate fixation to the bone; fixation is usually achieved by cementing the implant onto the bone.Some surgeons prefer to use biologic (noncemented) fixation.Although implants are firmly fixed at the initial ankle replacement surgery, they may become loose over time.The cause can be residual "boney" malalignment of the foot or poor functional balance and rom of the joint secondary to musculo-tendon contractures or imbalances between antagonistic muscle groups.Either of these can increase contact pressures at the articular surfaces of the components.Additionally, friction caused by the joint surfaces rubbing against each other wears away the surfaces of the implant, creating tiny particles that accumulate around the joint.In a process called aseptic (noninfected) loosening, the bond of the implant to the bone is destroyed by the body's attempt to digest the wear particles.During this process, normal bone is also digested (a condition called osteolysis), which can weaken or even fracture the bone.When the prosthesis becomes loose, the patient may experience pain, change in alignment, subsidence, or instability.Component loosening is the most common mode of failure of ankle implants(1,2).1.Escudero mi, le v, barahona m, et al.2019.Total ankle arthroplasty survival and risk factors for failure.Foot ankle int.40(9):997-1006.2.Penner m, davis wh, wing k, et al.2018.The infinity total ankle system: early clinical results with 2- to 4- year follow-up.Foot ankle spec :1938640018777601.Ifu states: the surgeon shall become thoroughly familiar with the technique of implantation of the prostheses by: (1) appropriate reading of the literature, and (2) training in the operative skills and techniques required for surgery, and (3) reviewing information regarding use of instrumentation.This device is used for treatment not diagnosis.Based on review of all available information, there is no evidence to reasonably suggest the reported event is related to any manufacturing issues or design issues.The study patient is reported to be suffering pain along the posterior tibial tendon and possible loosening noted at 2-year follow up x-ray.Loosening is a known cause for orthopedic revision surgery.An investigation was conducted; the loosening reported was likely the result of an insufficient bond between the implant and the bone, which led to possible aseptic (non-infected) loosening.However, this cannot be confirmed as the patient has not been revised.Information was not provided for: pt.Info.

Manufacturer Narrative

H11: (b)(4)- this medwatch [1038671-2022-10083] is rescinded as it is a duplicate of 1038671-2022-00288 -search of maude database shows that mfr 1038671-2022-00288 was accepted on 28 mar 2022.

Event Description

It was reported from the vantage total ankle study, that a patient experienced possible loosening noted at 2-year follow up x-ray.Action taken: medication.The case report form indicates this event is possibly related to the devices and related to the procedure.The patient is also suffering pain along posterior tibial tendon.No additional information is available.

• Brand Name: EXACTECH
• Type of Device: TIBIAL PLATE FB SZ 3 LT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 14210229
• MDR Text Key: 299274490
• Report Number: 1038671-2022-10083
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 350-11-03
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 52 KG