Catalog Number 5530-G-311 |
Device Problem
Naturally Worn (2988)
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Patient Problems
Failure of Implant (1924); Pain (1994); Device Embedded In Tissue or Plaque (3165)
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Event Date 10/08/2015 |
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 retained by 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.
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Event Description
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The physician revised a triathlon cr beaded femur and a primary tibia baseplate for universal due to instability.Left knee.Update as per maude report #mw5058475, doa (b)(6) 2016: voluntary (b)(6) 2015 12:59:07.00: i had a total left knee replacement with a stryker triathlon implant in (b)(6) 2009.I continued to have knee pain as well as pain down my leg.I was told to continue physical therapy.After 3 years the implant started to fail.I continued to have knee pain in the back/inside of my knee for 3 more years.After 6 years, i ended up having a total knee revision in (b)(6) 2015 because the implant failed.They replaced it with the stryker triathlon again with a stem in my femur and added a stabilizer.I wore through the tibial insert and triathlon baseplate and had metal shavings floating around my knee.
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Manufacturer Narrative
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An event regarding wear involving a triathlon cr x3 tibial insert was reported.The event was not confirmed.Method & results: - 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: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.
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Event Description
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The physician revised a triathlon cr beaded femur and a primary tibia baseplate for universal due to instability.Left knee.Update as per maude report #mw5058475, doa 1/4/2016: voluntary 14-dec-2015 12:59:07.00: i had a total left knee replacement with a stryker triathlon implant in (b)(6) 2009.I continued to have knee pain as well as pain down my leg.I was told to continue physical therapy.After 3 years the implant started to fail.I continued to have knee pain in the back/inside of my knee for 3 more years.After 6 years, i ended up having a total knee revision in (b)(6) 2015 because the implant failed.They replaced it with the stryker triathlon again with a stem in my femur and added a stabilizer.I wore through the tibial insert and triathlon baseplate and had metal shavings floating around my knee.
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Search Alerts/Recalls
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