STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 6 RIGHT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5542-A-602 |
Device Problem
Osseointegration Problem (3003)
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Patient Problems
Injury (2348); Inadequate Osseointegration (2646)
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Event Date 07/29/2019 |
Event Type
Injury
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Manufacturer Narrative
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A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There has been one other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not available.
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Event Description
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It was reported that the patient's right knee was revised due to femoral component loosening.The patient's entire knee construct (femoral component, stem, augments, insert, tibial baseplate with stem) were revised to a distal femoral replacement due to the patient's poor bone quality.No allegations against the tibial baseplate or liner were reported to the rep.Rep reported that no further information is available.
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Search Alerts/Recalls
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