Model Number 1504-10-105 |
Device Problem
Noise, Audible (3273)
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Patient Problems
Adhesion(s) (1695); Edema (1820); Pain (1994); Injury (2348); No Code Available (3191)
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Event Date 09/17/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.(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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Attune claim letter received.Litigation record alleges personal injury occurred as a direct result of defective manufacturing depuy attune knee device implanted.Doi: may 30, 2017; dor: unknown; unknown side.
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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.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed corrected: e2 and removed e3.
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Search Alerts/Recalls
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