Catalog Number 103547000 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Fall (1848); Joint Dislocation (2374)
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Event Date 10/10/2023 |
Event Type
Injury
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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 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
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Event Description
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It was reported that the patient fell post op and dislocated.Stem was swapped for cemented construct since the fall loosened the stem shortly after surgery.The loosening interface of stem is non-cemented, cement manufacturer is unknown.Constrained total hip was implanted to avoid future dislocations.Doi: (b)(6) 2023; doe: (b)(6) 2023; affected side: left hip.
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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.An evaluation of the manufacturing record could not be performed as the required lot number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.
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Search Alerts/Recalls
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