[63511455]
Race: white, not hispanic/latino. Slipped and fell at work. Workman comp denied mri, 2 months later approved a scope where class 3 tears were found in the cartilage and removed causing bone on bone ware. Eventually they approved the left knee arthroplasty using the stryker triathlon. Immediately, it felt as if i was on a bind. I alerted the doctor who said it may be normal, i have had trouble ever since. I continued seeing the doctor and even getting second and third opinions whom requested revision. I have since experienced worsening nerve damage, less and less mobility including pain 24/7 to be denied anymore procedures through workman's comp even after doctor's requests to revise knee. I was never told of a software recall of the shapematch cutting guides. I came across it while doing research on symptoms. I have received the operative notes from my doctor with the bar codes and waiting for the hospital notes with the software used. Workman's comp is still denying my revision per doctor's order. Fda class 1 recall notice. Stryker orthopaedics - shapematch cutting guide: class 1 recall [posted 04/18/2013]. Audience: surgery, risk manager. Issue: fda notified healthcare professionals of a class 1 recall for this product due to a software defect that results in wider cutting ranges. The parameters of the manufactured cutting guides may not meet the surgeon's pre-operative planning parameters entered via the web application. Additionally, stryker orthopaedics determined that another software defect resulted in the displayed parameters (e. G. Depth of resection, angle of cut) not matching the cutting guides produced. This may result in serious adverse health consequences including joint instability, fracture, need for revision surgery and chronic pain and limitations of mobility. The fda has received a total of 44 reports (41 malfunctions and 3 temporary medically reversible injuries) of incidents related to the shapematch cutting guides. Background: the shapematch cutting guides are single-use, disposable, cutting guides. They are intended to be used as surgical instrumentation to assist in the positioning of total knee replacement (arthroplasty) components intraoperatively and in guiding the marking of bone before cutting. In november 2012, stryker orthopaedics e-mailed field locations, registered surgeons and imaging centers of the problem and to immediately stop prescribing, planning or performing operative or imaging procedures with the shapematch cutting guides until further notice.
Patient Sequence No: 1, Text Type: D, B5