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Catalog Number UNK HIP ACETABULAR CUP |
Device Problem
Unintended Movement (3026)
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Patient Problem
No Code Available (3191)
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Event Date 04/19/2019 |
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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It was reported that according to the orthopaedic fellow, patient felt a "crack/pop" in his hip and scheduled an appointment with the surgeon.X-rays revealed superior position of the femoral head contained inside of the acetabular shell.The surgeon suggested revision surgery that week, but the patient rescheduled for a later date.It was discovered intra-op that the liner had dissociated from the pinnacle shell.4 ard tabs were completely gone.The surgeon chose to revise the acetabular shell due to the damage of the id of the shell from the femoral head articulating with it.A competitor's acetabular component and a depuy femoral head was placed.Doi: about 10 years; dor: (b)(6) 2019, right 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.Product complaint # (b)(4).No device associated with this report was received for examination.Examination of the provided photograph confirmed the reported event.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number 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.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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Product complaint # (b)(4).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.Product complaint # (b)(4).It should be noted no device was returned however a photo of the device was returned and confirmed the end cap of the handle had broken off.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot = null.Device history batch = null.Device history review = null.
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Search Alerts/Recalls
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