STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON SOLID PS TIBIAL INSERT TRIAL SIZE 2 - 14MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Model Number 5532-T-214Y |
Device Problem
Packaging Problem (3007)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/24/2020 |
Event Type
malfunction
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Manufacturer Narrative
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If additional information is received, it will be provided in a supplemental report upon completion of the investigation.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.The following devices were also listed in this report: triathlon solid ps tibial insert trial size 2 - 19mm; cat#: 5532-t-219y; lot#: a1qax.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
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Event Description
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In in-coming inspection at distribution, it was found that the item number on the label and the item number on the unit didn't match.This event was found on 1 of 15pcs of 5532-t-214y, lot# a1qcw, received on po# 60088308, inv# 50565638.Item#: (label): 5532-t-214y, item#: (unit): 5532-t-219y.
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Event Description
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In in-coming inspection at distribution, it was found that the item number on the label and the item number on the unit did not match.This event was found on 1 of 15pcs of 5532-t-214y, lot#: a1qcw, received on po#: (b)(4), inv#: (b)(4).Item#: (label) : 5532-t-214y; item#: (unit) : 5532-t-219y.
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Manufacturer Narrative
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Reported event: an event regarding product mix involving a triathlon trial was reported.The event was confirmed on review of the returned device.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device found a device with a label which states catalogue number 5532-t-214y while a review of the device in the actual bag found a device with catalogue number 5532-t-219y engraved on device material analysis, functional and dimensional inspections were not performed as these aspects are not in question.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 have been no other similar events for the lot referenced.Conclusions: visual inspection of the returned device found a device with a label which states catalogue number 5532-t-214y while a review of the device in the actual bag found a device with catalogue number 5532-t-219y engraved on device.
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Search Alerts/Recalls
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