Model Number L98015 |
Device Problem
Material Deformation (2976)
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Patient Problem
Limb Fracture (4518)
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Event Date 01/03/2022 |
Event Type
Injury
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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 stem distal slots deformed intro-op.The patient underwent the hip revision surgery with corail revision stem.During the surgery, it was found that the stem distal slot passed out of the femur and the distal slot was deformed.Then the surgeon removed the deformed stem timely and used another revision stem to complete the surgery.The patient was stable now.
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Event Description
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Additional information received states that there was a surgical delay of 1.5 hours.The affected side of the patient was the left hip.
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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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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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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: photo investigation and visual examination of the returned device confirmed the reported allegation.The distal tip prongs are bent in an outward direction.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: a manufacturing record evaluation was performed for the finished device lot# 5374668, and no non-conformances related to the malfunction were identified.Device history review: a manufacturing record evaluation was performed for the finished device lot# 5374668, and no non-conformances related to the malfunction were identified.
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Search Alerts/Recalls
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