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Catalog Number UNK KNEE PATELLA |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
No Consequences Or Impact To Patient (2199); Injury (2348); Osteolysis (2377)
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Event Date 01/04/2019 |
Event Type
Injury
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.This report is for an unknown device/unknown lot.Part and lot number are unknown; udi number is unknown.(b)(4).
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Event Description
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Patient was revised to address loosening of the femur and tibial components at the cement to implant interface.Cement manufacturer is unknown.This patient has a left total sigma cr knee with severe osteolysis and bone loss.Tibial insert has severe oxidation, wear, pitting, and yellowing.The patella was retained.It is unknown when this knee was implanted.Doi: unknown; dor: (b)(6) 2019, left knee.
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Manufacturer Narrative
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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.Additional narrative: product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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 : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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