STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Model Number 5532-G-409 |
Device Problems
Unstable (1667); Positioning Problem (3009)
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Patient Problems
Injury (2348); No Known Impact Or Consequence To Patient (2692)
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Event Date 01/14/2020 |
Event Type
malfunction
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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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During medical procedure, the surgeon found that tibial insert was very hard to implant.After beat several times, the surgeon felt tibial insert was instability.And then, the surgeon took the tibial insert out to implant again.But, the wire was out of insert and could not be used again.Finally, the other replacement was used to finish procedure.The surgery was delay nearly 1 hour.
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Event Description
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During medical procedure, the surgeon found that tibial insert was very hard to implant.After beat several times, the surgeon felt tibial insert was instability.And then, the surgeon took the tibial insert out to implant again.But, the wire was out of insert and could not be used again.Finally, the other replacement was used to finish procedure.The surgery was delay nearly 1 hour.
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Manufacturer Narrative
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An event regarding seating/locking issue involving traithlon insert was reported.The event was confirmed.Method & results: device evaluation and results: damage observed on the insert consistent with attempted implantation.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: the investigation concluded that damage observed on the insert consistent with attempted implantation.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examine.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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Search Alerts/Recalls
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