STRYKER GMBH SLIDING CORE UHMPWE, 6MM; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
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Catalog Number 400140 |
Device Problems
Entrapment of Device (1212); Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
No Code Available (3191)
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Event Date 10/17/2013 |
Event Type
Injury
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Manufacturer Narrative
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With guidance from the mdr policy branch of the fda, mdr reported by stryker (b)(4) as a result of a retrospective lookback of complaints resulting from the acquisition of assets from small bone innovation, inc.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.Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device is not available to stryker.
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Event Description
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Star poly exchange due to patient's impingement; poly was upsized.
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Event Description
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Star poly exchange due to patient's impingement; poly was upsized.
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Search Alerts/Recalls
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