Catalog Number UNK-HIP |
Device Problems
Migration or Expulsion of Device (1395); Loss of Osseointegration (2408)
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Patient Problem
No Information (3190)
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Event Date 09/02/2016 |
Event Type
Injury
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Manufacturer Narrative
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This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Depuy synthes has been informed that the catalog number and lot number is not available.
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Event Description
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Xray was received from surgeon, which showed a femoral stem in varus and too small for the patient.It also shows cup spinout and dislocation.
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Manufacturer Narrative
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Additional narrative: this complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
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Event Description
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A surgeon has expressed concerns regarding cases of pinnacle disassociation.No symptoms specific to this patient are known.X-ray image(s) have been provided.Per an image review, the acetabular cup has rotated well out of its initial position and a dislocation is evident.
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Manufacturer Narrative
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No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.The investigation could not draw any conclusions regarding the reported event.Based on the inability to determine a root cause, the need for corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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Search Alerts/Recalls
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