STRYKER ORTHOPAEDICS-MAHWAH NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 22MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5537-G-522 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Unspecified Infection (1930); Injury (2348)
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Event Date 07/07/2015 |
Event Type
Injury
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Manufacturer Narrative
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No 5.Triathlon ts plus tibial insert x3 poly 22mm; cat# 5537-g-522; lot# mkh59l.The following other devices were also listed in this report: tri ts femur sz6 right; cat# 5512-f-602; lot# fwvj.Tri ts baseplate size 5; cat# 5521-b-500; lot# jtwm.Triathlon symmetric x3 patella; cat# 5550-g-360; lot# xlpw.Tri post augment sz6 10mm; cat# 5544-a-600; lot# jasu.Triathlon femoral distal augment 10mm - size 6 right; cat# 5541-a-602; lot# itmj.Triathlon femoral distal augment 10mm - size 6 right; cat# 5541-a-602; lot# jkfm.Tri press-fit stem 25mm x 100mm; cat# 5565-s-025; lot# m5h16d.Tri press-fit stem 24mm x 100mm; cat# 5565-s-024; lot# m8t33.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.This event was reported via clinical outcomes reporting studies.An evaluation of the device cannot be performed as the device was not made available to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
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Event Description
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On (b)(6) 2015, patient had all components revised and underwent first stage of a two stage exchange utilizing a hinged knee system.
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Manufacturer Narrative
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An event regarding infection involving a no 5.Triathlon ts plus tibial insert x3 poly 22mm was reported.The event was not confirmed.Method and results: device evaluation and results: could not be performed as no items associated with the event were returned or made available for identification or evaluation.Medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: review of the device history records indicates all devices accepted into final stock met specifications.Complaint history review: there have been no other events for this lot and sterile lot.Conclusions: the source of the infection could not be determined as patient information, clinical history, and results of bloodwork for infection were not provided.A capa trend analysis was conducted for the reported failure mode and concluded infection is most likely a result from other factors not necessarily related to the device in the healthcare facility setting.No further investigation for this event is possible at this time as no devices and/or insufficient information was received by stryker orthopaedics.If devices and/or additional information become available, this investigation will be reopened.
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Event Description
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On (b)(6) 2015, patient had all components revised and underwent first stage of a two stage exchange utilizing a hinged knee system.
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Search Alerts/Recalls
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