Model Number 1137-08-000 |
Device Problems
Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/29/2021 |
Event Type
Injury
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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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Implants removed during revision - believed to be due to poor placement of humeral stem in too much anteversion.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: 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 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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