Catalog Number 5520B500 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bruise/Contusion (1754); Pain (1994); Injury (2348)
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Event Date 09/16/2015 |
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.
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Event Description
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Patient stated that he sustained an injury to his left knee while playing racquetball in the summer of 2013 when he "pulled" something that caused pain and caused his left leg becoming black and blue all the way up the back of the leg.He was not seen by his orthopedic surgeon at the time of the injury but was seen for a few visits in 2014 and 2015 with increasing symptomatology at each visit to the point where the surgeon opted for revision.
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Manufacturer Narrative
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An event regarding revision involving instability following a trauma of a triathlon baseplate was reported.The event was confirmed.Method & results: -device evaluation and results: not performed as the device was not returned for evaluation.-medical records received and evaluation: medical review indicates that: a racquetball injury of the knee caused ligament injury to the left knee arthroplasty with global instability as adverse outcome.Tibial baseplate exchange from ps to ts with a thicker ts bearing was required to address the instability.There are no x-rays available for review, so no evaluation of implantation related factors for instability are possible.Given the trauma as initiating event, it would not be very likely that such factors would have played an important role but due to lack of information this aspect cannot be further detailed.The sports injury to the arthroplasty as such is a typically patient-related event that is beyond control of anyone and has no procedure-related or device-related aspects for both of which there is no information to suspect such.Root cause of this pi case is a patient-related factor and as such is not device-related.-device history review: the device was manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: based on the medical review provided a racquetball injury of the knee caused ligament injury to the left knee arthroplasty with global instability as adverse outcome.Tibial baseplate exchange from ps to ts with a thicker ts bearing was required to address the instability.The sports injury to the arthroplasty as such is a typically patient-related event that is beyond control of anyone and has no procedure-related or device-related aspects for both of which there is no information to suspect such.Root cause of this pi case is a patient-related factor and as such is not device-related.A capa trend analysis was conducted for the reported failure mode and concluded instability may result from other factors not necessarily related to the device.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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Patient stated that he sustained an injury to his left knee while playing racquetball in the (b)(6) 2013 when he pulled something that caused pain and caused his left leg becoming black and blue all the way up the back of the leg.He was not seen by his orthopedic surgeon at the time of the injury but was seen for a few visits in 2014 and 2015 with increasing symptomatology at each visit to the point where the surgeon opted for revision.Additional information attached in intake tab: the tibial baseplate and insert were explanted and an universal baseplate with stem extension and a new insert were implanted.
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Search Alerts/Recalls
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