Catalog Number 01.18.230 |
Device Problem
Device Issue (2379)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/20/2017 |
Event Type
malfunction
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Manufacturer Narrative
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On 17 august 2017 the r&d project manager performed a preliminary investigation based on the available images and commented as follows: in the images of both braoch and stem no particular sign can be noted.We will wait to receive the stem for dimensional controls: that in order to confirm the equivalence between broach and stem.To date, the root cause of the event cannot be determined.Batch review performed on 18 august 2017.Lot 170841: (b)(4) items manufactured and released on 06 april 2017.Expiration date: 2022-03-28.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.
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Event Description
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The surgeon tried to implant the amistem-h collared stem size 0 after rasping, but the stem was not able to fit in the canal prepared with broach size 0.It was floated about 5mm height.The surgeon simply change for new stem size 00 and it was fit and fixed strongly.Due to this event, the surgery was prolonged about 10 minutes.The surgery was completed successfully.
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Manufacturer Narrative
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On 15 september 2017 the r&d project manager performed a visual inspection of the retrieved stem and commented as follows: no particular signs can be noted, except some scratches on the neck probably due to the removal of the stem.A dimensional control has been performed, which identified nor anomalies nor defects.According to the dimensional control, the stem and the broach conform to the drawing.The root cause of the event cannot be determined.
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Search Alerts/Recalls
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