STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE 4 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5531G409 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/21/2018 |
Event Type
malfunction
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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.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.
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Event Description
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A pharmacist at the hospital reported the following event to the sales rep : "during a knee prosthesis implantation, the tibial insert could not be implanted because it was defective.Another device had to be opened.Consequences: disruption of service/work, material and financial loss.".
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Search Alerts/Recalls
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