(b)(4).Other device used: catalog #00771101020, m/l taper stem, lot #62130196.Catalog #00875101436, continuum, trilogy it, allofit it liner, lot #62157691 - manufactured by zimmer b.V., (b)(4).Catalog #00877503602, biolox delta head, lot #2686825- manufactured by zimmer (b)(4).It was noted from the operative notes that the trial components gave excellent fit and radiographs taken intraoperative ensure the proper sizing and position.Trial components were removed and final components were implanted.Leg lengths were measured to be equalized.Office visit notes state that the x-rays revealed few degrees varus on stem and some lucent lines.No change in position or fracture is noted.It was also noted that the patient's symptoms are concerning for early loosening.Review of the compatibility of the devices confirmed that these are an approved compatible combination.Product history search revealed no additional complaints against the related part and lot combinations.A definite root cause for the patient's pain cannot be confirmed with the informed provided.These devices are used for treatment.
|