Catalog Number 103540000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Injury (2348); Ambulation Difficulties (2544); No Code Available (3191)
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Event Date 11/17/2011 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.(b)(4).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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Ppf and sticker sheets received.Ppf alleges fracture of the bone and infection.The unknown hip implant has been added to captured the allegation of a fracture as its unknown where the fracture was.If/when more information is received, the pc will be updated as needed.Doi: (b)(6) 2011; dor: (b)(6) 2011 (left hip).
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Manufacturer Narrative
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Product complaint # (b)(4).
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Event Description
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Pfs alleges compartment syndrome and walking difficulty.After review of medical records patient was revised to addressed infected left total hip arthroplasty.Procedure notes indicated all gram stains as well as cell counts per high power field were acceptable limits showing no evidence of infection.Further dissection was performed down the femur show evidence of significant bone loss.After thorough inspection there was a significant medial bony deficit of approximately 8 cm.Added height of patient.Doi: (b)(6) 2011; dor: (b)(6) 2011; left hip.
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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.H10 additional narrative: product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot:null.Device history batch: null.Device history review: null.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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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.H10 additional narrative: product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.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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