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Case Report Program

Thumb Arthritis Management

Field Orthopaedics is committed to supporting the continued improvement of clinical practice. We appreciate that one of the best ways to do this is through the sharing of case reports. Our case report program provides a collection of user experiences with the GriplastyTM System across a variety of indications.

If you are interested in contributing to the program, please click on the button below to view the process and get in touch either directly via marketing@fieldorthopaedics.com or your local representative.

Submit a Case Report

FOR HEALTHCARE PROFESSIONALS ONLY.

It’s important to note that, like any medical device, the GriplastyTM System may not be suitable for all patients and there are potential risks associated with the procedure. We encourage healthcare professionals to carefully consider individual circumstances and consult with medical experts to determine the best treatment options. Transparency and patient safety are our top priorities, and we’re committed to providing accurate information and supporting our customers every step of the way.

For further information on limitations and potential risks please access product specific IFU’s.

What are the risks associated with a GriplastyTM CMC Suspensionplasty??

Contraindications, potential complications, warnings and precautions: 

In any surgical procedure, the potential for complications and adverse reactions exists. Contraindications include cases of inflammation, cases of active or suspected sepsis / infection and osteomyelitis, patients with certain metabolic diseases and applications that are not defined by the indications.

The risks and complications with these implants can include loosening, deformation or failure of the implant, acute post-operative wound infections and late infections with possible sepsis, thrombosis and embolism, wound hematoma and delayed wound healing, temporary and protracted functional neurological perturbation and tissue reactions as the result of allergy or foreign body reaction to dislodged particles.

All complications listed here are not typical of the Field Orthopaedics (FO) Extremity All Suture System (EASS) but are in principle observed with any implant.

Warnings and precautions related to the use of the EASS include; Re-operation to remove or replace implants may be required at any time due to medical reasons or device failure. If appropriate action is not taken, complications may occur; Use of an undersized anchor in areas of high functional stresses may lead to implant fracture and failure; All implants and instrumentation in the EASS are intended for single use only; re-use may cause product failure and could lead to disease transmission; Use of undersized/oversized drill/K-wire to generate anchor pilot hole may lead to implant failure fixation. Use drill and K-wire supplied with the implant; FO branded instrumentation is recommended for use in conjunction with EASS implants; Postoperatively, until healing is complete, the fixation provided by this device should be protected. The postoperative regimen prescribed by the surgeon should be strictly followed to avoid adverse stresses being applied to the implant; Detailed instructions on the use and limitations of the device should be given to the patient; Any decision to remove the device should take into consideration the potential risk to the patient of a second surgical procedure. Implant removal should be followed by adequate postoperative management; Preoperative and operating procedures, including knowledge of surgical techniques and proper selection and placement of the implant, are important considerations in the successful utilization of this device; Do not re-sterilize this device; Do not use beyond the expiration date listed on the label. The performance, safety, and/or sterility of the device cannot be assured beyond the expiration date; Remove items from sterile packages using aseptic techniques; Avoid excessive impaction during insertion as this may lead to inserter damage and/or breakage. If insertion resistance is encountered, do not impact harder. Replace the implant and repeat the drilling/insertion procedure; Visually inspect the inserter for potential bending, damage or breakage after each insertion; Instruments, and components such as K-wires, Drills, Anchor Holders and needles are to be treated as sharps; Instrument must be disposed of according to hospital policy and procedure.

These devices have not been evaluated for safety and compatibility in the MR environment. For further details, please consult the instructions for use.