Catalog Number 3L92513 |
Device Problems
Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395); Fitting Problem (2183)
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Patient Problems
Muscular Rigidity (1968); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Weakness (2145); Discomfort (2330); Injury (2348); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); No Information (3190); No Code Available (3191)
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Event Date 05/10/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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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Patient was revised to address subsidence.
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Manufacturer Narrative
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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.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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(b)(4).
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Event Description
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Pinnacle litigation record received.Litigation alleges discomfort, pain, stiffness and loss of motion.It was also stated that the patient is at risk for metal toxicity due to elevated cobalt and chromium metal ions, implant loosening, metallosis, necrosis, soft tissue damage, muscle damage and injury.
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Event Description
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In addition to what were previously alleged, pfs alleges right leg weakness and difficulty in going up and down the stairs.After the review of medical records, it was reported that the patient was revised to address loosening of the femoral stem.Revision notes reported subsidence and some movement of the stem due to incorrect fit.Removed metal poisoning and metallosis since they were not indicated in the revision notes.Voided liner since it was not revised.Voided previously reported unknown hip implant since it was confirmed that stem had loose and subsided.There is no lab results provided.
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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.
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Search Alerts/Recalls
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