STRYKER GMBH SLIDING CORE UHMPWE, 7MM; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
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Catalog Number 400141 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Pain (1994)
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Event Date 04/12/2016 |
Event Type
Injury
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Manufacturer Narrative
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Device will not be returned.If additional information becomes available it will be provided on a supplemental report.The reported device was manufactured and distributed by small bone innovation, inc., (b)(6) and implanted prior to howmedica osteonics corp.¿s purchase of certain assets of sbi on (b)(6) 2014.Stryker became legal manufacturer of this product on (b)(6) 2015 and has taken the responsibility for medical device reporting.Hospital will not release.
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Event Description
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Patient is scheduled for a revision on (b)(6) 2016.Sales rep reported "the patient felt discomfort.Medial gutter debridement.No visible cysts.Poly did not appear worn.X-rays were taken.Poly was replaced with another 7mm.Bone growth in the gutter of the medial malleolus.Patient was reported to have arthritis.
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Search Alerts/Recalls
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