STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 2.5 ACCOLADE (127 DEG) SIZE 2.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number 6021-2530 |
Device Problems
Metal Shedding Debris (1804); Device Dislodged or Dislocated (2923); Material Deformation (2976); Scratched Material (3020)
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Patient Problems
Injury (2348); Joint Dislocation (2374)
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Event Date 05/06/2018 |
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 events for the reported lot.There have been no other 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.
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Event Description
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Patient's hip was dislocated, and the head detached from the stem neck.Upon opening, the doctor discovered that the femoral component was damaged and the stem was then removed and replaced along with the femoral head and polyethylene liner.Images were received which show "pencilling effect" on stem.
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Manufacturer Narrative
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An event regarding disassociation involving an accolade stem that was mated with a metal head was reported.The event was confirmed through visual inspection of the provided photographs.The reported device was not returned however photographs were provided for review.The photographs shows a recently explanted head and stem.Scratches and debris on the head is consistent with in vivo use and a recently explanted device.The stem has blood and bony ingrowth visible on it.The neck of the stem appears worn with a pencilling effect.Only a partial view of the liner can be seen from one of the photographs which appears unremarkable.Medical records received and evaluation: not performed as no medical records were received for evaluation.Indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the reported lot.The exact cause of the reported event could not be confirmed based on the information provided.Further information such as such product return, pre and post operative x-rays, operative reports, as well as patient history and follow up notes are required to complete the investigation for determining a root cause.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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Event Description
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Patient's hip was dislocated, and the head detached from the stem neck.Upon opening, the doctor discovered that the femoral component was damaged and the stem was then removed and replaced along with the femoral head and polyethylene liner.Images were received which show "pencilling effect" on stem.
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Search Alerts/Recalls
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