MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 2,

Model Number OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 2,

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

Patient Problem Failure of Implant (1924)

Event Date 06/19/2019

Event Type  Injury  

Manufacturer Narrative

As reported by united kingdom national joint registry (uknjr), this (b)(6) y/o, 148 cm, (b)(6) kg (bmi=34), female patient underwent primary total prosthetic replacement using cement of the right knee via medial parapatellar approach on (b)(6) 2014.The indication for the index procedure was osteoarthritis.On (b)(6) 2019, approximately 57 months post implantation, the patient underwent revision due to instability.Follow-ups for additional information will not be performed for this complaint, information was submitted as complete by the (b)(6) registry; there is no identification of facilities or surgeons.All available information about the event or patient has been provided.These devices are used for treatment not diagnosis.It is found in a review of the labeling and ifu 700-096-004, it is known that device specific risks consist of: fracture, migration, loosening, subluxation, or dislocation of the prothesis or any of its components, any of which may require a second surgical intervention or revision.As part of the preoperative assessment, the surgeon must ensure that no biological, biomechanical, or other factors exist that might adversely affect the surgery and/or postoperative period.Revisions or surgical interventions are a known complication found in joint replacements.All patients should be instructed on the limitations of the prosthesis and the possibility of subsequent surgery.The patient should be cautioned to monitor activities and protect the replaced joint from unreasonable stresses and follow the written instructions of the physician with respect to follow-up care and treatment.The surgeon must be fully knowledgeable about all aspects of the surgical technique to use the implants in accordance with the indications and contraindications and be trained according to the proper use of the system instrumentation and implants.It is a known complication that a patient¿s age, weight, or activity level would cause the surgeon to expect early failure of the system.As noted in ¿why are total knee arthroplasties failing today¿has anything changed after 10 years?¿, the top five reasons for total knee arthroplasty revision/surgical intervention account for approximately 85% of the reasons that drive revision/surgical intervention.The failure mechanisms are as follows: 39.9% for loosening; 27.4% for infection; 7.35% for instability; 4.7% for periprosthetic fracture; and 4.5 % for arthrofibrosis.In early revisions (less than two years) infection was found to be the most common failure mechanism and late revisions show aseptic loosening as the most common reason.1 1.Sharkey, p.L.(2014, september).Why are total knee arthroplasties failing today¿has anything changed after 10 years?; the journal of arthroplasty, 29.Total knee replacement instability is noted to occur due to surgical techniques of creating excessive flexion gaps, inadequate filling of the extension space due to the components not being thick enough, soft tissue/ligament damage, and/or injury incurred during post-op rehabilitation therapy.2 2.Musculoskeletal key, (2018, october).Treatment of instability after total knee replacement; electronic source.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The knee instability reported was likely the result of patient conditions.The patient has a high bmi which indicates that they are overweight.Overweight patients increase biomechanical stressors on natural and artificial joints.This submission represents 1 of 163 events identified via active surveillance activities utilizing data form the united kingdom national joint registry (uknjr).Follow-ups for additional information cannot be performed for this complaint as the information was submitted as complete by the registry; there is no identification of facilities or surgeons.All available information about the event and/or patient has been provided and it is not possible to obtain any of the devices.

Event Description

As reported by united kingdom national joint registry (uknjr), this (b)(6) y/o, 148 cm, (b)(6) kg(bmi=34), female patient underwent primary total prosthetic replacement using cement of the right knee via medial parapatellar approach on (b)(6) 2014.The indication for the index procedure was osteoarthritis.On (b)(6) 2019, approximately 57 months post implantation, the patient underwent revision due to instability.Follow-ups for additional information will not be performed for this complaint, information was submitted as complete by the united kingdom national joint registry (uknjr); there is no identification of facilities or surgeons.All available information about the event or patient has been provided.These devices are used for treatment not diagnosis.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The knee instability reported was likely the result of patient conditions.The patient has a high bmi which indicates that they are overweight.Overweight patients increase biomechanical stressors on natural and artificial joints.

• Brand Name: OPTETRAK
• Type of Device: OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 2,
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523782617
• MDR Report Key: 9703607
• MDR Text Key: 194935560
• Report Number: 1038671-2020-00100
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862061744
• UDI-Public: 10885862061744
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K032606
• 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
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/28/2016
• Device Model Number: OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 2,
• Device Catalogue Number: 230-03-02
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 74