Model Number 1217-32-056 |
Device Problem
Migration (4003)
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Patient Problem
Insufficient Information (4580)
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Event Date 05/31/2022 |
Event Type
Injury
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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.Product complaint # (b)(4).
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Event Description
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Patient had right thr on (b)(6) 2022 by dr.At (b)(6) hospital.Patient dislocated same day as surgery and rotated acetabular cup.Revision was required by dr to remove cup, liner and head, and put in a more contained option.Reason for dislocation is unknown by surgeons.Doi: (b)(6) 2022, dor: (b)(6) 2022, right hip.
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Manufacturer Narrative
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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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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