STRYKER ORTHOPAEDICS-MAHWAH MODIFIED HOLLOW PS TIBIAL INSERT TRIAL #4 - 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5532-T-411A |
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 11/24/2015 |
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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Left total knee procedure, when trialing, insert trial cracked.
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Manufacturer Narrative
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Corrected lot number based on additional information.An event regarding damaged triathlon insert trail was reported.The event was confirmed.Method & results: device evaluation and results: a visual inspection confirms the reported damage.Medical records received and evaluation: not performed as clinical factors did not contribute to the event.Device history review: all devices accepted into final stock conformed to specification.Complaint history review: there have been no other events for the lot referenced.Conclusions: the investigation concluded that the reported event occurred as a result of multiple overload conditions during trialing.No material or manufacturing defects were identified.No further investigation for this event is possible at this time.If additional information become available, this investigation will be reopened and re-evaluated.
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Event Description
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Left total knee procedure, when trialing, insert trial cracked.
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Manufacturer Narrative
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Corrected lot number from ppm5607 to ppm5g07.During review of the complaint file it was noticed that lot number in supplemental #1 mdr was inadvertently changed from correct lot number ppm5g07 to incorrect ppm5607.
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Event Description
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Left total knee procedure, when trialing, insert trial cracked.
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Search Alerts/Recalls
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