STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON INSERT PS#8 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5532G813 |
Device Problems
Break (1069); Fracture (1260); Material Integrity Problem (2978)
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Patient Problems
Injury (2348); No Information (3190)
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Event Date 05/11/2016 |
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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Triathlon ps #8 x 13 post was broken.Implanted (b)(6) 2012.
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Manufacturer Narrative
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An event regarding fractured ps post involving a triathlon ps insert was reported.The event was confirmed.Method & results: -device evaluation and results: material analysis of the device indicated that the post of the x3 triathlon insert ps#8 13mm broke in fatigue with the fracture starting on the posterior surface and progressing in an anterior direction.Damage from contact with the femoral component was observed on the anterior side of the post.Burnishing, scratching and third body indentations were observed on the articulating surfaces of the insert and are commonly identified damage modes on uhmwpe inserts.No material or manufacturing defects were observed during this examination.-medical records received and evaluation: insufficient medical records were provided for review.-device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification.-complaint history review: complaint history review confirmed that there have been no other similar events for the reported lot.Conclusion: material analysis of the device indicated that the post of the x3 triathlon insert ps#8 13mm broke in fatigue with the fracture starting on the posterior surface and progressing in an anterior direction.Damage from contact with the femoral component was observed on the anterior side of the post.Burnishing, scratching and third body indentations were observed on the articulating surfaces of the insert and are commonly identified damage modes on uhmwpe inserts.No material or manufacturing defects were observed during this examination.The exact cause of the event could not be determined because insufficient information was provided.Further information such as further x-rays, operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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Triathlon ps #8x13 post was broken.Implanted (b)(6) 2012.
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Search Alerts/Recalls
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