STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN INSERT SIZE 10; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number UNK_JR |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/14/2019 |
Event Type
malfunction
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Manufacturer Narrative
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An event regarding size/fit issue involving an unknown insert was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned. clinician review: no medical records were received for review with a clinical consultant. device history review: not performed as no lot information was provided.Complaint history review: not performed as no lot information was provided.Conclusion: the exact cause of the event could not be determined because insufficient information was provided. additional information including device details, return of the device, photographs/video of the event as it happened and operative reports are required to fully investigate the event and determine a root cause.If further information becomes available or the product is returned, this investigation will be re-opened.
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Event Description
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During a tka case.Surgeon trailed a size 10 poly insert and put in the implant however the surgeon said that it didn't feel the same.The surgeon did the same procedure with a size 11 and did not like the implant and so he used a size 12 trail and liked the implant size.There is no additional information can be provided by the surgeon or hospital.No additional information will be available.
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Search Alerts/Recalls
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