STRYKER GMBH SLIDING CORE UHMPWE, 8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
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Catalog Number 400142 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Code Available (3191)
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Event Date 04/12/2013 |
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 gmbh, (b)(6) 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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Revision due to medial malleous osteotomy.
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Event Description
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Revision due to medial malleous osteotomy.
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Search Alerts/Recalls
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