MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; TRULIANT PS CEM FEM PS CEM RIGHT SZ 3

Catalog Number 02-020-11-0330

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Loss of Range of Motion (2032)

Event Date 12/13/2019

Event Type  Injury  

Manufacturer Narrative

As a result of an fda inspection conducted in jan 2020, exactech, fei (b)(4), has committed to remediating 3 years of complaints (2017-2020).This mdr is being submitted as part of that remediation.The device was available for analysis.Engineering analysis completed by ad on 9/9/2020.According to the information provided, approximately 12 months after the initial total knee replacement, a swap of the polyethylene insert was completed.This event was not reported to exactech when it occurred but has since been captured in (b)(4).Eight months after the polyethylene swap, the surgeon planned to revise the femur to address a flexion contracture.The surgeon began by using ¼ inch osteotome under femoral flange and the femur reportedly came entirely loose.There was no cement adhesion to the femoral component.The surgeon removed an additional 4mm of distal femur to address flexion contracture and implanted a size 3 ps femoral component with a 9mm insert.Design-related issues: as of 08/04/2020, exactech has received 7 complaint reports involving loosening of a truliant femoral component since its introduction in 2017.The sales data for all truliant femoral components was used to calculate a complaint occurrence rate of (b)(4).This is considered ¿very low¿ according to the frequency of occurrence ranking scale.Therefore, this does not appear to be design related.Mfg-related issues: exactech is not aware of receiving any other complaint reports involving a part from this packaging lot of (b)(4) pieces, which consisted of two (b)(4) manufacturing lots.5 of the (b)(4) pieces remain in inventory and, therefore, have not yet been implanted.A review of the device history record showed that the named device was accepted with conformance to the device requirements.Therefore, this does not appear to be manufacturing related.A review of the risk management report (rmr) and risk assessment and controls report (racr) was conducted to ensure the risk was included and the occurrence is below the threshold.The racr for this truliant femoral component, (b)(4) was reviewed.The risk is captured in risk id 7.8.Corrective actions are not required because the occurrence is ¿very low¿, loosening and ¿flexion contracture/varus valgus deformity¿ are both listed in the product labeling under device specific risks (ifu 700-096-160 rev c), and the risk is captured in the racr.The revision reported in (b)(4)was likely the result of the patient¿s flexion contracture.The loosening of the femoral component discovered during the revision was likely the result of an insufficient bond between the bone cement and the femoral component.Properly functioning implants depend on their appropriate fixation to the bone; fixation is usually achieved by cementing the implant onto the bone.Although implants are firmly fixed at the initial knee replacement surgery, they may become loose over time.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 (non-infected) 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, or instability.Aseptic loosening is the most common mode of failure of knee implants.Reference: scuderi gr, kochhar t: management of flexion contracture in total knee arthroplasty.J arthroplasty.2007, 22 (4 suppl 1): 20-4.10.1016/j.Arth.2006.12.110.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.It is a clinical standard of practice in the operating room that all instruments should be visually and functionally inspected before use, these guidelines are from standard association of peri-operative registered nurses (aorn) guidelines.Surgeons are to be familiar and knowledgeable with all instrumentation, devices and proficient with surgical techniques.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 patient had a surgical revision.The revision reported was likely the result of the patient¿s flexion contracture.The loosening of the femoral component discovered during the revision was likely the result of an insufficient bond between the bone cement and the femoral component.

Event Description

It was reported from the us that the patient¿s initial right tka procedure was done on (b)(6)2018.On (b)(6)2019 a poly swap was performed captured in mfr 1038671-2019-00628.On (b)(6)2019 the surgeon planned to revise the femur to address a flexion contracture.He began by using ¼ inch osteotome under femoral flange and the femur came entirely loose.No cement adhesion to the femoral component.He removed an additional 4mm of distal femur to address flexion contracture and re-implanted a size 3 ps femur with a 9mm poly.The device was received on 12/17/2019.Attempt was made for additional information from the representative and a response was received.Per the representative, no additional information is available about this event.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 patient had a surgical revision.The revision reported was likely the result of the patient¿s flexion contracture.The loosening of the femoral component discovered during the revision was likely the result of an insufficient bond between the bone cement and the femoral component.

• Brand Name: EXACTECH
• Type of Device: TRULIANT PS CEM FEM PS CEM RIGHT SZ 3
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 13198514
• MDR Text Key: 288700185
• Report Number: 1038671-2022-00022
• 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
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 02-020-11-0330
• Device Lot Number: 8110216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/10/2019
• Date Manufacturer Received: 12/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female