Model Number 1035-43-000 |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/13/2023 |
Event Type
malfunction
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Event Description
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It was reported that when assembling the ball head into bipolar head, surgeon followed as per manual and took out poly to place inner ball.He then placed the poly back into outer head and found that the poly had a bit of wobble and was worried that it did not seat properly.
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Manufacturer Narrative
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Product complaint # (b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.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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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.Device history lot : a manufacturing record evaluation (nc search) was performed for the finished device product code:103543000, lot-j33z00 number, and no non-conformances / manufacturing irregularities were identified.
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Search Alerts/Recalls
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