STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #6 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5531G611 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Wound Dehiscence (1154); Fall (1848)
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Event Date 03/15/2016 |
Event Type
Injury
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Manufacturer Narrative
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An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
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Event Description
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The patient fell one day post surgery and dehisced their surgical wound.Dr.(b)(6) decided to change the tibial insert after a vigorous washout.Nothing was loose or broke, no as stated by surgeon was fault on the implant.
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Manufacturer Narrative
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An event regarding unspecified revision involving a triathlon insert was reported.The event was not confirmed.Method and results: device evaluation and results: not performed as product was not returned medical records received and evaluation: not performed as no medical information was provided.Device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification.Complaint history review: complaint history review confirmed that there have been no other similar events for the reported lot.Conclusions: the patient fell one day post surgery and dehisced their surgical wound.The surgery completed a vigorous washout during which the reported insert was revised for unspecified reasons.It is reported that nothing was loose or broken.The exact cause of the event could not be determined because insufficient information was provided.Further information such as reason for revising the insert, product return, pre- and post-operative x-rays, operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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The patient fell one day post surgery and dehisced their surgical wound.Dr.(b)(6) decided to change the tibial insert after a vigorous washout.Nothing was loose or broke, no as stated by surgeon was fault on the implant.
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Search Alerts/Recalls
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