STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNC
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Catalog Number 625-0T-28D |
Device Problem
Device Difficult to Setup or Prepare (1487)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/07/2018 |
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 reported lot.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.Not returned / not received.
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Event Description
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During a hip replacement operation, the surgeon found that the trident alumina insert was properly installed, but the trident alumina insert can¿t fixed with trident hemispherical cluster and very easy fell off.
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Event Description
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During a hip replacement operation, the surgeon found that the trident alumina insert was properly installed, but the trident alumina insert can't fixed with trident hemispherical cluster and very easy fell off.
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Manufacturer Narrative
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An event regarding seating/locking issue involving a trident liner was reported.The event was not confirmed.Dimensional inspection: returned device, lot 47457705 (part 625-0t-28d), could not be disassembled to allow measurement of this part to be conducted.However, a review of the original dhr confirmed that all inspections on the lot were within specification at the time of manufacture as per (b)(4) ver.10 requirements.Functional inspection: a functional test was performed on the trident shell (part 502-01-50d, lot 53152101) and the trident ceramic liner (part 625-0t-28d, lot 47457705).There were no issues noted, both parts mated together without issue.Medical records received and evaluation: not performed as no medical records were returned for review.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there were no other events for the lot provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as the primary operative report is needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
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