Model Number 1570-04-070 |
Device Problem
Difficult to Remove (1528)
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Patient Problems
Fall (1848); Limb Fracture (4518)
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Event Date 01/09/2023 |
Event Type
Injury
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Event Description
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Revision of a c-stem.Female.Left side.The reason for revision was due to a periprosthetic fracture.Patient had a fall.The c-stem and head were removed, and reclaim was implanted.Duraloc cup and liner were left in situ.Stryker (dall-miles) cables were used for closure of proximal bone.It was also challenging to remove the poly taper protector from the reclaim stem 1977-20-190 lot: 651324.This added a 5min delay to remove.The patient had a revision on (b)(6) 2022 where the charnley elite stem, head, and duraloc liner were removed.The reason for this revision was due to poly wear which had caused the stem to loosen, and caused significant bone loss.A c-stem was implanted, and poly was replaced with a marathon poly.Stryker cables (dall-miles) were also used.
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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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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.Device history lot : a manufacturing record evaluation (nc search) was performed for the finished device 157004070, lot d21082496, and no non-conformances / manufacturing irregularities were identified.
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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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Event Description
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Additional information received indicated that the patient had a fall which caused the periprosthetic fracture and the need for revision.
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Search Alerts/Recalls
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