Catalog Number UNK KNEE INSTRUMENT |
Device Problem
Defective Device (2588)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/24/2018 |
Event Type
malfunction
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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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Der states patient had attune revision rp implants placed.Surgeon did not like the way the tibial insert trial moved on the trial tibia or on the real implant.It does not replicate the actual feel of the real implant and does not accurately reproduce the final implant.He is not able to assess his flexion stability with the trial implants and may return to using the sigma revision system until a change is made to the trials.Doe: (b)(6) 2018.
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Manufacturer Narrative
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Product complaint (b)(4).Investigation summary no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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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Search Alerts/Recalls
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