STRYKER ORTHOPAEDICS-MAHWAH TRI TS FEMUR SZ1 RIGHT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5512-F-102 |
Device Problems
Mechanical Problem (1384); Loss of Osseointegration (2408); Insufficient Information (3190)
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Patient Problem
Injury (2348)
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Event Date 06/27/2016 |
Event Type
Injury
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Manufacturer Narrative
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An evaluation of the device cannot be performed as the device remained implanted in the patient 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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The subject is enrolled in the post market triathlon ts outcomes study.The site called me today to inform me that subject (b)(6) is scheduled to have revision surgery on (b)(6) 2016.At this time it is uncertain which components will be removed, however in the surgeon's chart, it is believed that the femoral component and possibly tibial insert/component may be removed/revised.More information will be available after the surgery takes place as the surgeon will better determine the outcomes/what is revised after starting the surgery.
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Manufacturer Narrative
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An event regarding loosening & pain involving a triathlon femoral component was reported.The event was confirmed.Method & results: device evaluation and results: explanted device images were provided which depicts that femoral component is well fixed with long-stem.The cemented femoral component is surrounded by radiolucency with only distal cement noted.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated "no dated serial x-rays and no examination of the explanted components are available.Based upon the information available for review, no determination can be made for the cause of the apparent loosening of the revision femoral component in the right total knee arthroplasty three-and-a-half years after implantation." device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: there has been no other event for the lot referenced.Conclusions: based upon the medical records, patient was revised due to pain and loosening of femoral component.A review of the provided records by a clinical consultant indicated that "no dated serial x-rays and no examination of the explanted components are available.Based upon the information available for review, no determination can be made for the cause of the apparent loosening of the revision femoral component in the right total knee arthroplasty three-and-a-half years after implantation." no further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and/or additional information become available, this investigation will be reopened.
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Event Description
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The subject is enrolled in the post market triathlon ts outcomes study.The site called me today to inform me that subject 65-08-022r is scheduled to have revision surgery on (b)(6) 2016.At this time it is uncertain which components will be removed, however in the surgeon's chart, it is believed that the femoral component and possibly tibial insert/component may be removed/revised.More information will be available after the surgery takes place as the surgeon will better determine the outcomes/what is revised after starting the surgery.
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Search Alerts/Recalls
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