Model Number 1217-32-056 |
Device Problems
Device Dislodged or Dislocated (2923); Naturally Worn (2988)
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Patient Problems
Foreign Body Reaction (1868); No Code Available (3191)
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Event Date 09/23/2020 |
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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It was reported that the liner was either never full engaged with cup or became disassociated from cup.The ceramic femoral head then became in contact with the inner diameter of the acetabular shell.With the ceramic head articulating with the inner diameter of the shell, the shell became compromised causing metallosis and the ceramic head eventually wearing/cutting through the acetabular shell.It is not certain that the liner became disassociated or was improperly placed as there was an unseated screw that was removed.Also, the liner was severely compromised.Doi: (b)(6) 2017, dor: (b)(6) 2020, affected side: unknown.
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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.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.
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Search Alerts/Recalls
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