STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON FEMORAL DISTAL AUGMENT 5MM - SIZE 1 RIGHT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5540-A-102 |
Device Problems
Loose or Intermittent Connection (1371); Mechanical Problem (1384); Loss of Osseointegration (2408)
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Patient Problems
Pain (1994); Injury (2348)
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Event Date 06/27/2016 |
Event Type
Injury
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.
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Event Description
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The subject is enrolled in the post market (b)(4) study.Patient was revised due to pain and femoral component loosening.
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Manufacturer Narrative
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An event regarding pain and loosening involving a triathlon augment was reported.The event was confirmed.Method and results: -device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.-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 (b)(4) study.Patient was revised due to pain and femoral component loosening.
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Search Alerts/Recalls
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