BIOMET, INC. FEMORAL COMPONENT; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/PO
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Catalog Number 161468 |
Patient Problems
Pain (1994); Ambulation Difficulties (2544); Cramp(s) /Muscle Spasm(s) (4521); Swelling/ Edema (4577)
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Event Date 04/17/2019 |
Event Type
Injury
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Event Description
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Event description: it was reported that on (b)(6) 2019, the patient had swelling and it was loose in knee.Patient had x-rays and it was confirmed that it was loose.Not infected had bloodwork done to make sure.Patient was taking naproxen 500 mg for the swelling and to help with the pain and meds were prescribed by surgeon.Patient was also taking methocarbamol for muscle spasms 500 mg.Patient ice most evenings for swelling and pain.Patient had a hard time walking.This was a full right knee replacement performed by surgeon at hospital.Patient had since retired.So patient saw another doctor local just for x-rays and to get some meds.Patient should not have another surgery so soon and be in this kind of pain.Reference reports: mw5144586, mw5144588, mw5144589.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
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