STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BASEPLATE - CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5520-B-400 |
Device Problem
Failure To Adhere Or Bond (1031)
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Patient Problem
No Code Available (3191)
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Event Date 05/29/2012 |
Event Type
Injury
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Manufacturer Narrative
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The following devices were also listed in this report: triathlon cr fem comp #4 l-cem; cat# 5510-f-401; lot# s4d8y.Triathlon symmetric x3 patella; cat# 5550-g-298 lot# exde.X3 triathlon cs ins size 4 9mm; cat# 5531-g-409; lot# lcp064.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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.Device not returned to the manufacturer.
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Event Description
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Patient had a left knee revision due to aseptic loosening.
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Manufacturer Narrative
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An event regarding loosening involving a triathlon baseplate was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as the product was not returned.-medical records received and evaluation: not performed as no medical records were provided.-device history review: indicated the device was manufactured and accepted into final stock with no reported discrepancies.-complaint history review: indicated that there have been no other similar reported events for the lot referenced.Conclusions: the exact cause of the reported loosening could not be determined with the limited information provided.Further information such as product return, x-rays, operative notes, medical records and follow-up notes are needed to complete the investigation to determine a root cause.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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Patient had a left knee revision due to aseptic loosening.
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