Catalog Number 5532-G-413 |
Device Problem
Material Too Rigid or Stiff (1544)
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Patient Problems
Muscular Rigidity (1968); Loss of Range of Motion (2032)
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Event Date 06/01/2015 |
Event Type
Injury
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Event Description
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Patient had a left knee revision due to patient complaining of not getting full flexion and having tightness in the knee joint.Surgeon replaced patient's 13mm insert with an 11mm insert.All other components were well fixed with no issues.
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Manufacturer Narrative
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An event regarding stiffness leading to revision surgery involving a triathlon insert component was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as no product was returned for evaluation.-medical records received and evaluation: not performed as no medical records were received.-device history review: dhr review was satisfactory.-complaint history review: chr review confirmed that there were no other similar events reported for the lot.Conclusions: the reported event cannot be confirmed with the information provided.The exact cause of the event could not be determined with the limited information provided.Further information such as x-rays, operative reports, patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If the device or additional information becomes available, this investigation will be reopened.
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Event Description
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Patient had a left knee revision due to patient complaining of not getting full flexion and having tightness in the knee joint.Surgeon replaced patient's 13mm insert with an 11mm insert.All other components were well fixed with no issues.
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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.
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Search Alerts/Recalls
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