STRYKER GMBH TALAR COMP,SINGLE COATED US VERS SMALL, LEFT; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
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Catalog Number 400255 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Post Operative Wound Infection (2446)
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Event Type
Injury
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Manufacturer Narrative
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The reported device was manufactured and distributed by small bone innovation, inc., (b)(4).Stryker corporation purchased this product line on april 1, 2015 and will take the responsibility for medical device reporting.Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device remains implanted.
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Event Description
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Subject received a star in the left ankle on (b)(6) 2016.Subject presented with erythema around the star incision site on (b)(6) 2016 and was prescribed antibiotics and instructed to watch the area.Subject was admitted to the hospital on (b)(6) 2016 with a wound infection brought on by an allergic reaction from the topical antibiotic ointment or the vaseline gauze (reported by pi).I/d on (b)(6) 2016 revealed pseudomonas aeruginosa.The subject was treated in the hospital with iv antibiotic and discharged on (b)(6) 2016.Subject was instructed to take antibiotic by picc line at home and to return to the office for follow-up on (b)(6) 2016.
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Search Alerts/Recalls
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