Catalog Number L20413 |
Device Problems
Fitting Problem (2183); Material Deformation (2976); Scratched Material (3020); Appropriate Term/Code Not Available (3191)
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Patient Problem
Not Applicable (3189)
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Event Date 09/25/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (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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The surgeon was performing an anterior total hip arthroplasty using a corail stem.He sank the size 13 broach to the cut surface; however, as he was implanting the size 13 kho collarless corail stem, the stem was sitting up significantly from where the broach sank.He explanted the 13 kho and implanted another 13 kho, still sitting proud significantly.I am sending back the size 13 broach and the size 13 kho stem we explanted to be evaluated.Dr.(b)(6) asked to speak to a member of the manufacturing department and he asked for a response to this device report.Doe: (b)(6) 2019.Right hip.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : examination of the returned broach finds nothing outward to suggest product error.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 : null.Device history batch : null.Device history review : null.
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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).Investigation summary: examination of the returned broach finds nothing outward to suggest product error.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, 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.
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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.
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Event Description
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It was reported that there was 10 minutes surgical delay.
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Search Alerts/Recalls
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