Model Number 1217-22-052 |
Device Problem
Naturally Worn (2988)
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Patient Problems
Pain (1994); No Code Available (3191)
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Event Date 07/03/2019 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter is 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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Unf and pinnacle medical records received.After review of medical records the patient was revised to address instability due to fall resulting to dislocation and pain.Operative note reported hip was found dislocated.There is a mild scratching on the trunnion and acetabular cup.Intra-operative mentioned, the constrained liner bent.Another liner was impacted.X-ray result confirmed the dislocation.Doi: (b)(6) 2018; dor: (b)(6) 2019; left 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.
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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.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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