Catalog Number 201001100 |
Device Problems
Fitting Problem (2183); Appropriate Term/Code Not Available (3191)
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Patient Problem
Not Applicable (3189)
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Event Date 03/04/2019 |
Event Type
malfunction
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
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Event Description
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Broach and implant did not seem to match.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary = > related dimensional examination of the returned product found no discrepancy from drawing requirements.No product problem identified.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.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.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. 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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