Model Number L20311 |
Device Problems
Loss of or Failure to Bond (1068); Use of Device Problem (1670); Osseointegration Problem (3003)
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Patient Problems
Inadequate Osseointegration (2646); Insufficient Information (4580)
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Event Date 03/02/2022 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).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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Surgeon revised corail pinnacle with well fixed cup on the patients right side for stem loosening and malposition after 9 years.The cup was retained and all other components revised.Plan a was a sas b pinnacle dual mobility cup with corail pinnalce, or corail revision.Surgeon changed his mind and implanted an s-rom hip with sas b pinnacle dual mobility liner and bearing, off label usage.Followed up with au marketing and this complaint raised.Surgeon did not have any concerns post follow up as required a dual mobility due to chasing offset, plan b for the cup would have been a stryker mdm component which would have been off label usage.Doi: unknown.Dor: unknown.Unknown hip.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Updated device code osseointegration problem to loss of or failure to bond.
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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.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation (mre) was not possible because the required lot code was not provided.
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Search Alerts/Recalls
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