Model Number 1024-52-500 |
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 12/01/2021 |
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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I was present during a sigma partial knee surgery at (b)(6) on the (b)(6) 2021.All the cuts and trialling of the partial knee went well and it was accepted the sz5 rm tibial tray, 7mm rm sz 5 insert and sz 5 femur rm, were to be used as the definitive implants.On implantation both the tibial tray and the femur were inserted and cemented in place.On insertion of the poly insert, it was noted that it was not seating anteriorally.The poly was removed and the checks on cement over hang and debris in the tray took place.It was then re inserted but again did not fully seat.The steps were repeated again but at this time it was noted the poly had deformation anteriorally due to being impacted to try and seat it, but possible damge to the poly locking rails on the underside of the insert were observed.The poly was removed and swapped for an 8mm sz 5 rm, due to only 1 x 7mm being on the loan set.The steps were repeated again with the 8mm poly but again it did not appear to seat fully.An impator was use to push the poly into place.The surgeon noted the poly had a slight 1 mm spring anteriorally, however accepted this as he believed the poly to be securely in place.
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Event Description
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Additional information received indicated that the affected side involved in this event was the right knee medial side rm.
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Manufacturer Narrative
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Product complaint # : (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report 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 was performed for the finished device 102452500, lot jf9464, and no non-conformances / manufacturing irregularities were identified.
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Search Alerts/Recalls
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