Model Number 38AM-4600 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Loss of Range of Motion (2032); Reaction (2414); Metal Related Pathology (4530)
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Event Type
Injury
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Event Description
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Allegedly, patient is suffering from mom complications to include: acetabular cup loose, elevated ion levels, impaired gait and failure of bony ingrowth.(left).Additional information received from litigation on 01/08/2019.Allegedly the patient was revised due to unknown mom complications.Added the explant date.
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Event Description
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Allegedly, patient is suffering from mom complications to include: acetabular cup loose, elevated ion levels, impaired gait and failure of bony ingrowth.Additional information received from litigation on 01/08/2019.Allegedly the patient was revised due to unknown mom complications.Added the explant date.(left).
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Manufacturer Narrative
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Updated incident description, initial reporter and event problem codes.The investigation previously reported remains unchanged.
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Search Alerts/Recalls
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