STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG INSERT 36MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
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Model Number 623-00-36D |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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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.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.Not returned.
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Event Description
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It was reported that during a mako tha, the liner would not lock into the trident ii 48mm shell.The liner was removed and a second liner (same catalog #, different lot) also would not lock into the shell.Surgeon decided to implant an mdm metal liner and adm/ mdm poly insert instead, and also 'down-sized' the stem to accommodate.The first 2 liners were from loaners.Surgery was completed with a delay of approximately 30 minutes.The stem needed to be changed because we were going to use a 4; which is a 35mm neck.He was going to use a 36mm minus head but since the 36mm liners would not lock in, he had to drop down to a 3 stem which is 5mm less neck length and use a plus head option.
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Manufacturer Narrative
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Reported event: an event regarding seating/locking issues involving a trident liner was reported.The event was not confirmed.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs shows a trident liner with nothing remarkable to report.From the photographs provided there is no evidence of the seating locking issues.Medical records received and evaluation: no medical records were received for review with a clinical consultant.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 has been no other similar events for the lot referenced.Conclusions: the reported device was not returned however photographs were provided for review.The photographs shows a trident liner with nothing remarkable to report.From the photographs provided there is no evidence of the seating locking issues.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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It was reported that during a mako tha, the liner would not lock into the trident ii 48mm shell.The liner was removed and a second liner (same catalog #, different lot) also would not lock into the shell.Surgeon decided to implant an mdm metal liner and adm/ mdm poly insert instead, and also 'down-sized' the stem to accommodate.The first 2 liners were from loaners.Surgery was completed with a delay of approximately 30 minutes.The stem needed to be changed because we were going to use a 4; which is a 35mm neck.He was going to use a 36mm minus head but since the 36mm liners would not lock in, he had to drop down to a 3 stem which is 5mm less neck length and use a plus head option.
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