Catalog Number 487-S000 |
Device Problems
Device Expiration Issue (1216); Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/07/2015 |
Event Type
Injury
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Event Description
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Allegedly, implant was implanted 3 months after expiry date.The date of the original surgery (b)(6) 2015.A sales representative was present during the procedure.There surgery did not extend over 30 minutes.Additional information received via email on 7/1/2015 from michel fleury: in israel a hospital implanted a lpt implant that was expired on march 2015.Implantation site/procedure: hmiarthoplasty.
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Manufacturer Narrative
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Investigation not complete.Product has not been returned.Trends will be evaluated.This report will be updated when the investigation is complete.
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Manufacturer Narrative
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Investigation complete, the product was sold by wright medical well before the expiration date.The expiration of the implant was not noticed either by the distributor or the hospital before implantation.There were no complaints related to infection that was received by wright medical , after implantation of this particular expired product.
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Search Alerts/Recalls
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