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It was reported that a patient had a right tka procedure on (b)(6) 2014 during which the patella was not resurfaced.
The surgeon performed a revision right tka on (b)(6) 2017 due to tibial loosening.
During the revision procedure the surgeon explanted the following arthrex products: tibial tray, ar-503-tttj, lot 108761232, femoral implant, ar-503-psrj, lot 108761216, and bearing implant, ar-503-bj18, lot 113601221.
The revision procedure was completed using another manufacturer's product.
It has been reported that the surgeon chose not to request patient authorization to return explants for evaluation and the explants were discarded at the time of surgery.
Additional information obtained from patient medical records: records dated (b)(6) 2015: records noted patient also has a history of gastric bypass surgery for morbid obesity.
Records dated (b)(6) 2015: records noted patient was obese at (b)(6) lbs (which is a contraindication for tka - patient's weight at the time of (b)(6) 2014 surgery is unknown).
Records dated (b)(6) 2016: x-ray findings right knee -prosthesis in place in proper anatomical alignment without rotation, loosening or stress shielding.
X-rays show periarticular osteophytes and joint space narrowing.
Examination of the right knee demonstrates swelling but no erythema and no ecchymosis.
Palpation of the right knee demonstrates medial joint line, medial tibial plateau and lateral tibial plateau tenderness.
Patient was tender on the right at diffuse.
Mild effusion of the right knee was noted.
(b)(6) 2016 records also noted that on (b)(6) 2015 patient was working when a semi truck's gas tank exploded above him.
Explosion caused patient to go down on both knee's.
Patient blacked out and woke up at hospital.
X-rays taken - no fx seen right knee effusion.
Records noted patient did not have pain prior to the injury.
Also noted, patient's bone scan showed possible loosening after the fall.
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