Catalog Number 01.26.65.35 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/14/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Batch review performed on 14 october 2015: lot 148376: (b)(4) items manufactured and released on 26 march 2015.Expiration date: 2020-02-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.On 01 october 2015 the r&d project manager analyzed the retrieved head of the screw: signs can be seen on the head of the screw: they can be caused by the repeated contact between the head of the screw and probably the shell during the insertion of the screw.The thread of the screw is not available, so we cannot reach any other conclusion.It is not possible to determine any conclusion on the root cause of the problem.
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Event Description
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Whilst screw being placed into acetabular cup - head sheared off - head retained for analysis.However thread left in place - embedded below cup so no interference with liner.
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Manufacturer Narrative
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On 04 dec 2015 it was prepared a final report with the information already submitted in the initial report.On 12 dec 2015 it was sent to the initial reporter and the case was closed.
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Search Alerts/Recalls
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