STRYKER GMBH SLIDING CORE, UHMPWE 14MM REVISION; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
|
Back to Search Results |
|
Catalog Number 99002814 |
Device Problem
Appropriate Term/Code Not Available (3191)
|
Patient Problem
No Code Available (3191)
|
Event Date 05/21/2013 |
Event Type
Injury
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
Revision surgery due to syndesmosis instability.
|
|
Event Description
|
Revision surgery due to syndesmosis instability.
|
|
Search Alerts/Recalls
|
|
|