STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5530-G-409 |
Device Problems
Crack (1135); Fracture (1260); Material Integrity Problem (2978); Naturally Worn (2988)
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Patient Problems
Pain (1994); Injury (2348)
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Event Date 08/24/2016 |
Event Type
Injury
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Manufacturer Narrative
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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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A revision procedure was undertaken due to patient complaining of severe pain.Upon removal of the tibial insert there was noticeable wear on the lateral side, as well as a crack in the implant.
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Manufacturer Narrative
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Corrected data: device not returned.An event regarding crack/fracture involving a triathlon insert was reported.The event was confirmed.Method & results: -device evaluation and results: not performed as the device was not returned.-medical records received and evaluation: the provided medical information was submitted to a consulting clinician who confirmed the cracked insert and subluxation of femoral component with provided undated x-rays.He deemed the information insufficient and rejected it for a medical review.-device history review: all devices in the reported lot were 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 provided medical information was submitted to a consulting clinician who confirmed the cracked insert and subluxation of femoral component with provided undated x-rays but deemed the information insufficient and rejected it for a medical review.Further information such as return of the device, dated x-rays, operative reports, patient history, clinical notes and examination of explanted components 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, this investigation will be reopened.
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Event Description
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A revision procedure was undertaken due to patient complaining of severe pain.Upon removal of the tibial insert there was noticeable wear on the lateral side, as well as a crack in the implant.As per consulting clinician on (b)(6) 2016: the femoral component was noted as subluxing as per undated x-ray.
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Search Alerts/Recalls
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