Catalog Number 136352000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); No Code Available (3191)
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Event Date 10/07/2019 |
Event Type
Injury
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Manufacturer Narrative
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(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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Left hip revision - patient complained of hip pain.Original date of surgery (b)(6) 2018.Converted hemi hip to total hip - removed stem, cathcart and sleeve.Was surgery delayed due to the reported event? --> no.Was procedure successfully completed? --> yes.Were fragments generated? --> unknown.If yes, were they removed easily without additional intervention? --> unknown.Patient status/ outcome / consequences --> unknown.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> unknown.Is the patient part of a clinical study --> unknown.(b)(4).Device property of -->none.Device in possession of -->none.(b)(4).Device property of -->none.Device in possession of -->none.(b)(4).Device property of -->none.Device in possession of -->none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.--> true.
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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.Corrected: h6.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, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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