Model Number 56-3618 |
Device Problems
Difficult to Remove (1528); Device-Device Incompatibility (2919)
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Patient Problems
Cyst(s) (1800); Foreign Body Reaction (1868); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Necrosis (1971); Sepsis (2067); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
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Event Date 12/16/2022 |
Event Type
Injury
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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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Event Description
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Clinical notification received for revision due to infection.Date of implant: (b)(6) 2006, date of revision: (b)(6) 2022, (right hip).Treatment: revision; head, liner and shell were revised.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: the device associated with this report was not received for examination.Based on the visual analysis of the provided photographic evidence for device, it cannot be determinate a depuy's device failure or malfunction which could contribute to reported event.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: 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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