Model Number 1518-20-038 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Edema (1820); Unspecified Infection (1930); Pain (1994); No Code Available (3191)
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Event Date 10/28/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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 adverse event received for septic knee: infection - deep.Event is serious and is considered severe.Event is definitely related to device and is possibly related to procedure.Date of event (onset): (b)(6) 2020.(right knee).Treatment: awaiting revision surgery.
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Manufacturer Narrative
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Product complaint # (b)(4).No device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history review : 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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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