It was reported a patient began to experience limited range of motion, difficulty ambulating, pain, swelling, and stiffness about one month post implantation, underwent a manipulation under anesthesia.The scar tissue was easily released and the procedure was completed without complications.All implants remain in place.
|
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted. additional associated products: 42530007102, persona tibia trabecular metal 2-peg porous fxd brg rt size e, lot #: 64077537.42522100810, persona articular surface medial congruent (mc) right 10 mm, lot #: 64375813.00587806532, nexgen complete knee solution, trabecular metal std pri patella, lot #: 64227939.
|