STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #7 16MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5531G716 |
Device Problem
Material Deformation (2976)
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Patient Problem
Injury (2348)
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Event Date 01/16/2013 |
Event Type
Injury
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Manufacturer Narrative
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Review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.
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Event Description
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Patient's wife called stating her husband had a stryker total knee implanted in 2014.10 months post-implant, knee was revised due to a damaged poly insert (patient's wife reported the device was "torn up" and "in chunks").Patient's wife specified implant took place (b)(6) 2012, revision (b)(6 2013.
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Manufacturer Narrative
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It has been discovered that this pi is a duplicate of 2249697-2012-02077.Therefore, it will be cancelled.
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Event Description
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Patient's wife called stating her husband had a stryker total knee implanted in 2014.10 months post-implant, knee was revised due to a damaged poly insert (patient's wife reported the device was "torn up" and "in chunks").Patient's wife specified implant took place (b)(6)2012 revision (b)(6)2013.
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Search Alerts/Recalls
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