SMITH & NEPHEW, INC. GII C/R HA POROUS FEM SZ 7LT; PRSTHSS,KNEE,PTLL/FMRTBL,SM-CNSTRND,UNCMNTD,PRS,CTD,PLYMR/MTL/PLYMR
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Model Number 71422050 |
Device Problem
Scratched Material (3020)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/01/2020 |
Event Type
malfunction
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Event Description
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It was reported that during the procedure of bilateral tkr the implant was scratch.The surgeon had the option of placing a the oxonium implant (backup from smith+nephew), but it decided to finish the procedure with the implant scratched.The procedure had a delay between 0-30 min.
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Manufacturer Narrative
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The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Damage from improper handling is a likely probable cause of the reported event.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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Search Alerts/Recalls
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