Catalog Number 150610003 |
Device Problems
Loss of or Failure to Bond (1068); Use of Device Problem (1670)
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Patient Problems
Pain (1994); Not Applicable (3189); No Code Available (3191)
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Event Date 05/09/2018 |
Event Type
Injury
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Patient was revised to address loosening of the tibia at the cement to implant interface, unknown cement manufacturer was used.Doi: (b)(6) 2015, dor: (b)(6) 2018, left knee.
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Manufacturer Narrative
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(b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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On (b)(6) 2018, the patient underwent a left knee revision due to pain, tibial tray malpositioning and loosening at the cement to implant interface.Two depuy cement products were used during the primary operation.
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Manufacturer Narrative
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Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report. (b)(4).
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Search Alerts/Recalls
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