Model Number 1365-40-740 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Ecchymosis (1818); Erythema (1840); Fall (1848); Fever (1858); Unspecified Infection (1930); Swelling/ Edema (4577)
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Event Date 09/09/2021 |
Event Type
Injury
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Event Description
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On (b)(6) 2021 physical therapy notes stating the left hip demonstrates an effusion and the patient has recently fallen.Physical therapy notes on (b)(6) 2021 state the left hip is very swollen, red, and hard.The patient also states he may have had a low grade fever.The treatment was not completed due to concerns over infection.Notes detail a physical therapy evaluation performed on (b)(6) 2021.The notes state the left hip is bruised with a significant effusion.This pc was created to capture the harm reported post left hip revision on (b)(6) 2021.
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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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 product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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