MAKO SURGICAL CORP. MCK FEMORAL-LM-RL-SZ 5; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
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Catalog Number 180505 |
Device Problems
Loss of Osseointegration (2408); Insufficient Information (3190)
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Patient Problem
Inadequate Osseointegration (2646)
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Event Date 04/04/2016 |
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 retained by the hospital and 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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Dr.(b)(6) revised a patients mako partial knee replacement due to loosening of the femoral component.He changed the femoral component, original size was a 5 left medial, and he downsized to a 4 left medial.He also removed the tibial insert which was originally a 6x9mm, and inserted a 6x10mm.
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Manufacturer Narrative
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An event regarding loosening involving a mck femoral lm-rl sz 5 was reported.The event was not confirmed.Method & results: device evaluation and results: visual, dimensional, and functional inspection were not performed as the item was not returned.Medical records received and evaluation: not performed as medical records were not provided.Device history review: review of the device history records indicates 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 could not be confirmed nor the root cause of the reported event determined due to the minimal information received for evaluation.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopedics.If additional information becomes available, this investigation will be reopened.
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Event Description
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Dr.(b)(6) revised a patients mako partial knee replacement due to loosening of the femoral component.He changed the femoral component, original size was a 5 left medial, and he downsized to a 4 left medial.He also removed the tibial insert which was originally a 6x9mm, and inserted a 6x10mm.
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Search Alerts/Recalls
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