STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #7 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5531G711 |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/09/2019 |
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 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.Device not returned.
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Event Description
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Primary procedure, right knee.It was reported that when opened, the device had what appeared to be a long black hair wrapped around it.Due to sterility concerns, the implant was not used.A second device of the same catalog number (different lot) was obtained and implanted.Surgery was completed successfully with a delay of less than one minute.Rep provided the usage sheet showing the wasted implant and reported that no further information will be released by the hospital or surgeon.
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Search Alerts/Recalls
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