Catalog Number 121730500 |
Device Problems
Migration or Expulsion of Device (1395); Migration (4003)
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Patient Problems
Host-Tissue Reaction (1297); No Information (3190)
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Event Date 11/21/2011 |
Event Type
Injury
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Event Description
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Pfs and medical records received.It should be noted these records were received through a pfs.Formal litigation hasn¿t been filed yet, so this complaint isn't legal.Pfs alleges pain, itching, and hives for 2 years.Part/lot information provided.After review of the medical records the patient was revised for pain and the head and liner were revised.The screw in the cup was also prominent so it is also being reported for migration.
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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.Additional narrative: 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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Manufacturer Narrative
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The devices associated with this report were not returned.Per wi-3430, a review of the device history records is no longer required for the metal head and metal liner provided product and lot combinations.A complaint database search finds no other reported incidents against the remaining product and lot combination.Medical records were provided and reviewed by a medical professional.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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Manufacturer Narrative
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(b)(4).
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Event Description
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Ppf alleges abductor muscle repair.
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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.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.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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Search Alerts/Recalls
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