Catalog Number UNK-HIP |
Device Problems
Appropriate Term/Code Not Available (3191); Noise, Audible (3273)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994)
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Event Date 07/28/2014 |
Event Type
Injury
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: unavailable.This complaint is the subject of litigation or a legal claim and complete product detail is not available at this time.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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Litigation papers allege that after surgery, the patient experienced severe pain in the right thigh and groin.Patient also experienced clicking in the hip joint when walking or moving, diagnoses of high metal levels and a pseudotumor in the right hip.
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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 was not provided.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.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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