Model Number 2544-01-014 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/19/2021 |
Event Type
malfunction
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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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It was reported that this patient had a left total attune knee.During reassembly of the instruments, it was noticed that a retaining spring on the spacer block was missing.It is unknown if the spring was left in the patient.No surgical delay.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : examination of the returned confirmed the reported event.The investigation could not identify a root cause for the missing balseal spring without the spring component to examine.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.
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Search Alerts/Recalls
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