Catalog Number UNK BROACH |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/16/2022 |
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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It was reported that the surgeon prepared the canal for a corail 125 degree standard collar corail size 12.The surgeon broached progressively to size 12 and took x-rays.The surgeon used a calcar planer and everything looked good.However upon inserting the stem it would not seat flush to the calcar and was 7 centimeters proud which is unacceptable.The surgeon is a participant in dots with depuy clinical orthopedics.A great deal of the information am be obtained from them.There is no reported loosening.There is a reported surgical delay of 5 minutes.Doe: (b)(6) 2022; affected side: unknown.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : no device was received for examination, therefore the reported event could not be confirmed.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 : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
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Search Alerts/Recalls
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