STRYKER GMBH SLIDING CORE UHMPWE, 10MM; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
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Catalog Number 400144 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Code Available (3191)
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Event Date 11/18/2014 |
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 (b)(4).The reported device was manufactured and distributed by (b)(4) and implanted prior to howmedica osteonics corp.¿s purchase of certain assets of (b)(4) on august 1, 2014. stryker became legal manufacturer of this product on april 1, 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.The device is not available to stryker.
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Event Description
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Revision surgery due to no plantar or dorsal flexion.
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Search Alerts/Recalls
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