STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5532-G-409-E |
Device Problems
Device Damaged Prior to Use (2284); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/27/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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.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.H3 other text : device not returned to the manufacturer.
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Event Description
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When the iud was removed from the packaging during implantation, it had a loose locking wire.The surgeon had to take another implant, this one was not implanted.
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Manufacturer Narrative
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Reported event: an event regarding disassociation involving a triathlon insert was reported.The event was confirmed via the provided photograph of the device.Method & results: -product evaluation and results: the reported device was not returned; however, a photograph was provided for review.The photograph shows the insert in a plastic bag with labels.The labels partially obscure the view of the insert but it appears that the locking wire has completely disassociated from the poly insert.Nothing further can be observed from the photograph.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate 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 lot referenced.Conclusions: it was reported that the locking wire came loose from the triathlon insert during surgery.The reported device was not returned; however, a photograph was provided for review.The photograph shows the insert in a plastic bag with labels.The labels partially obscure the view of the insert but it appears that the locking wire has completely disassociated from the poly insert.Nothing further can be observed from the photograph.Further information such as return of the device is needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If device(s) and/or 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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When the iud was removed from the packaging during implantation, it had a loose locking wire.The surgeon had to take another implant, this one was not implanted.
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Search Alerts/Recalls
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