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Additional information: age or date of birth, weight; event; brand name, common device name, device manufacture date.An event regarding incorrect cuts by surgeon involving a triathlon patella was reported.The event was not confirmed however, pain and patient factors were confirmed by medical review.Method & results: product evaluation and results: not performed as the device was not returned.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: ¿her past medical history includes osteoarthritis of the knees, hypertension, lumbar fusion in 2015, hypothyroidism, injections including visco supplement injections to her knees, physical therapy and pain medication.On (b)(6) 2016, she underwent a primary left cemented total knee arthroplasty for a diagnosis of "left knee oa and morbid obesity".The operative report describes general anesthesia and the use of a tourniquet, as well as computer navigation.The report notes, "knee could not be flexed so provisional freehand cuts to the femur and tibia before the computer navigation could be introduced were performed.A freehand cut of the patella was also performed." ¿on (b)(6) 2016, office visit the patient was noted to be four weeks' post-operative complaining of "4/5 knee pain, dull and diffuse, moderate stiffness and swelling.Hasn't been able to get adequate physical therapy".The note continues, "physical examination: moderate effusion, incision healed well, 0° to 90°, no instability.X¬ ray: stable tka, no loosening, migration or subsidence.Physical therapy, outpatient, ordered." on (b)(6) 2016 she was seen and it was noted, "pain improving, 3/5, intermittent, 0° to 120°, flexes without pain, no instability.X-ray unchanged.Continue p.T., decrease narcotics, and return two months." ¿on (b)(6) 2016 a manipulation under anesthesia of the left total knee was performed for a diagnosis of a stiff left total knee arthroplasty.The operative report describes general anesthesia and a pre-operative range of motion of 0° to 85° and a post-operative range of motion of 0° to 120° with no instability and "patella tracked well".On (b)(6) 2016 office visit she presented with "pain, 3/5, dull in quality; 0° to 90°, no instability; plan: decrease pain meds, return four weeks".When seen on (b)(6) 2016 the note states," mild stiffness, moderate discomfort, return to most activities of daily living.Physical examination: 0° to 120° with no pain or instability, mild effusion.X-ray unchanged.Impression: stable left tka, return six months." ¿x-ray printouts related to the left knee include a series dated on (b)(6) 2016, which are two ap's, a lateral and a patellar view of the left knee, as well as an ap of both knees demonstrating advanced tri-compartmental osteoarthritis, primarily involving the medial compartment with a varus deformity of the knee.A large osteochondral body is noted proximal to the patella.X-rays dated on (b)(6) 2016 is an ap of both knees, a lateral of the left knee, two ap's of the left knee, a long bone study, and a patellar view of the left knee, which is poorly visualized, demonstrating a cemented left total knee arthroplasty with cemented long modular tibial stem, tibial plateau augments, a ps femur, a ts insert, components in nominal position, and the osteochondral body previously noted has been removed.Restoration of the mechanical axis of the knee is noted.X-rays dated on (b)(6) 2016 are multiple views of the left knee, which are unchanged from the previous description.A lateral patellar tilt is noted on the patellar views.No clinical follow-up subsequent on (b)(6) 2016 office visit and x-rays and no description of symptoms in the past year are available.In this excellent reconstruction of an advanced osteoarthritic knee with a varus deformity, osteochondral fragments and chronic post-operative low back pain some persistent discomfort is not unexpected.There is no evidence of any current clinical problems related to the positioning, design, manufacture or material of the total knee arthroplasty components in this patient's left knee.Morbid obesity, arthrofibrosis, and reflex sympathetic dystrophy may have contributed to her reported symptoms.¿ product history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: the investigation concluded that the pain was caused by patient factors such as morbid obesity, arthrofibrosis and reflex sympathetic dystrophy.The clinician concluded, ¿in this excellent reconstruction of an advanced osteoarthritic knee with a varus deformity, osteochondral fragments and chronic post-operative low back pain some persistent discomfort is not unexpected.There is no evidence of any current clinical problems related to the positioning, design, manufacture or material of the total knee arthroplasty components in this patient's left knee.¿ no further investigation for this event is possible at this time.If devices and/or additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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