STRYKER ORTHOPAEDICS-MAHWAH MODIFIED HOLLOW PS TIBIAL INSERT TRIAL #6 - 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5532-T-611A |
Device Problems
Break (1069); Crack (1135); Fracture (1260); Material Integrity Problem (2978)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/04/2016 |
Event Type
malfunction
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Manufacturer Narrative
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When completed, the investigation results will be submitted in a supplemental report.
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Event Description
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It was reported that during a right total knee surgery, the surgeon put in trial and checked for range of motion and upon removal of the trial, the trial cracked.No delay or adverse consequence and surgery completed without further incident.
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Manufacturer Narrative
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An event regarding an alleged fracture involving a triathlon modified insert trial was reported.The event was confirmed.Method and results: device evaluation and results: visual inspection indicated a 1/2 inch long portion of the bottom edge had fractured and separated from the device.An examination of the device by the materials analysis team using a stereo microscope indicated hackles (crack branching) resulting from fast fracture overload had occurred.Medical records received and evaluation: no patient information was provided.Device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: the event was confirmed.Visual inspection indicated a 1/2 inch long portion of the bottom edge had fractured and separated from the device.An examination of the device by the materials analysis team using a stereo microscope indicated hackles (crack branching) resulting from fast fracture overload had occurred.
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Event Description
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It was reported that during a right total knee surgery, the surgeon put in trial and checked for range of motion and upon removal of the trial, the trial cracked.No delay or adverse consequence and surgery completed without further incident.
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Search Alerts/Recalls
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