STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #5; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Model Number 5520-B-500 |
Device Problems
Osseointegration Problem (3003); Insufficient Information (3190)
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Patient Problems
Pain (1994); Injury (2348)
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Event Date 03/03/2020 |
Event Type
Injury
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Manufacturer Narrative
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Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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On (b)(6) 2020, a revision of triathlon that was implanted in 2014.The revision occurred due to aseptic loosening of tibial component.The existing femur component remained stable and was left insitu.The tibia baseplate and insert were removed and replaced with a universal baseplate and 9/100mm stem, tibia cone and cs insert.The procedure doesn¿t require monitoring.The outcome of the procedure was a successful revision.
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Event Description
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On 3/3/20, a revision of triathlon that was implanted in 2014.The revision occurred due to aseptic loosening of tibial component.The existing femur component remained stable and was left insitu.The tibia baseplate and insert were removed and replaced with a universal baseplate and 9/100mm stem, tibia cone and cs insert.The procedure doesn¿t require monitoring.The outcome of the procedure was a successful revision.
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Manufacturer Narrative
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Reported event: an event regarding loosening involving a triathlon baseplate was reported.The event was confirmed.Method & results: product evaluation and results: not performed as the device was not returned.Medical records received and evaluation: a brief operative report for a right tka with bacteriology reports and surgical pathology reports negative for infection [.] x-rays: an undated ap both knees and lateral right demonstrating the same tka with lucency's around the tibial component consistent with loosening on lateral view.Review of this additional data confirms the event description.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of the provided medical records by a clinical consultant confirms the event description.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
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Search Alerts/Recalls
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