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

Model Number TIBIAL PLATE FB SZ 3 LT

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

As a result of an fda inspection conducted in jan 2020, exactech, fei 1038671, has committed to remediating 3 years of complaints (2017-2020).This mdr is being submitted as part of that remediation.Cat#350-21-13; sn not reported; product description -fixed bearing liner component and cat# 350-01-03; sn not reported; product description-talar component.Device remains implanted.Design-related issues: the design of the vantage ankle has been in the field since 2015.Since 2015, exactech has received 6 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.Mfg-related issues: the tibial implant is a packaging lot comprised of two split manufacturing lots of 17 and 23 units.The talar implant is a packaging lot comprised of two split manufacturing lots of 23 and 22 units.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 iron mountain.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 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 (non-cemented) 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 :(b)(4).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.

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 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th ct.; gainesville FL
• Manufacturer Contact: kate jacobson
• MDR Report Key: 13928035
• MDR Text Key: 288688827
• Report Number: 1038671-2022-00288
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152217
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TIBIAL PLATE FB SZ 3 LT
• Device Catalogue Number: 350-11-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/15/2019
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 03/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 114 KG
• Patient Race: White