Catalog Number 121725500 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Pulmonary Embolism (1498); Cardiac Arrest (1762); Infarction, Cerebral (1771); Unspecified Infection (1930)
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Event Date 03/25/2010 |
Event Type
Injury
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Event Description
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New etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint.-litigation alleges that the patient suffers from ongoing infection.Doi: (b)(6) 2010 - dor: (b)(6) 2010 (right hip).Patient is a resident of (b)(6).Update rec¿d (b)(6) 2014¿ medical records received.Part/lot was provided.After review of the medical records it confirmed the patient was revised on (b)(6) 2010 for retained infection.The unknown depuy hip is being changed to the cup.Eight screws, liner, femoral head, and hole eliminator are being reported for infection.The stem and sleeve were previously reported in (b)(4) for infection.The patient had antibiotic spacers placed (b)(6) 2010.There is no new additional information that would affect the existing mdr decision.The complaint was updated on : (b)(6) 2014.
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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.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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Update rec'd 11/8/2012¿ pfs and medical records received.After review of the medical records the patient actually had ongoing infection and the implants were removed on (b)(6) 2010 and spacers placed so the dor needs to be changed to (b)(6) 2010.The spacers were removed and new implants placed on (b)(6) 2010.There is no new additional information that would affect the existing mdr decision.
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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.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.A review of the device history records for the b53bg4000 and bc8c74000 lot codes did not reveal any related manufacturing deviations or anomalies.A complaint database search finds no other reported incidents against the remaining product and lot combinations.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.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 stroke, heart attack, pulmonary embolism and reported that the patient is deceased, reason and date of death were not provided.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.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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Search Alerts/Recalls
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