STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 5 RIGHT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5541-A-502 |
Device Problem
Mechanical Problem (1384)
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Patient Problems
Pain (1994); Injury (2348)
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Event Date 07/19/2018 |
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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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As reported: "this subject is a participant in the (b)(6) study.An adverse event form was received on july 31, 2018 noting that this subject had a revision of the femoral component on (b)(6) 2016 due to progressive loosening of the femoral component.No other previous adverse event forms had been submitted.The 2-year follow-up visit on (b)(6) 2016 noted that the subject was experiencing moderate pain".
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Event Description
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As reported: "this subject is a participant in the triathlon ts outcomes study.An adverse event form was received on july 31, 2018 noting that this subject had a revision of the femoral component on (b)(6) 2016 due to progressive loosening of the femoral component.No other previous adverse event forms had been submitted.The 2-year follow-up visit on (b)(6) 2016 noted that the subject was experiencing moderate pain".
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Manufacturer Narrative
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An event regarding loosening involving a triathlon augment was reported.The event was confirmed.Method & results: device evaluation and results: not performed as the reported device was not returned for evaluation.Medical records received and evaluation: a medical review noted; review of these records confirms revision tka for femoral component loosening occurred, however, the root cause cannot be determined as insufficient information was available device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.Conclusion: a medical review concluded loosening however the root cause could not be determined.Further information such as additional imaging and laboratory reports related to the two revision surgeries & implant retrieval with material analysis are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.
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Search Alerts/Recalls
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