Model Number 2545-00-545 |
Device Problems
Entrapment of Device (1212); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint #: (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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Voluntary report was received under mw5101410.It was reported that the orthopedic surgeon used a depuy ortho attune articulating surface trial for a knee replacement.On a post procedure xray, it was found what look like a small spring in back of the knee joint.It was discovered to have come off the attune articulating surface trial device.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: the device associated with the reported event was not returned for examination.The investigation could not draw any conclusions about the reported event based on the limited information provided.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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