STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5532-G-613 |
Device Problems
Device Dislodged or Dislocated (2923); Insufficient Information (3190)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 02/02/2017 |
Event Type
malfunction
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Manufacturer Narrative
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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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Wire came out of the poly insert at time of impaction.The surgeon removed the wire and poly, wasted the defective implant and replaced with a new same size implant.
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Manufacturer Narrative
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An event regarding a seating/locking issue involving a triathlon insert was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the device was not returned for evaluation.Medical records received and evaluation: not performed as no medical records were provided.Device history review: indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: chr review for the reported lot confirmed that there are no other similar events reported.Conclusions: the exact cause of the event could not be determined because the devices were not returned for evaluation and no medical information was provided.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information becomes available, this investigation will be reopened.
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Event Description
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Wire came out of the poly insert at time of impaction.The surgeon removed the wire and poly, wasted the defective implant and replaced with a new same size implant.
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Search Alerts/Recalls
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