Catalog Number UNK-HIP |
Device Problems
Metal Shedding Debris (1804); Appropriate Term/Code Not Available (3191)
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Patient Problems
Pain (1994); Ambulation Difficulties (2544); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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For any product information received.This complaint is the subject of litigation or a legal claim and currently 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.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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Event Description
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Litigation alleges patient suffers from pain, elevated ion levels and metal debris, and difficulty ambulating.
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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.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.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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Manufacturer Narrative
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After review of the medical records, it has been determined that this product has been reported twice.This duplication is an error.This report will be rejected.
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Search Alerts/Recalls
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