Catalog Number 01.26.45.1150 |
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 11/08/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Preliminary investigation performed by r&d project manager on 01 december 2017: the image provided by the complainer was checked: after the preliminary investigation, no particular defects in geometry were noticed.In fact the correct design of the cup is not totally symmetric, due to the presence to a shoulder: in the rim area of the superior quadrant of the shell, the rim is thinner due to the presence of a big radius.A further analysis will be performed as soon as the cup returns to medacta international.Batch review performed on 04 december 2017: (b)(4).
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Event Description
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According to the surgeon and the or staff, the connection hole of the versafictup cc trio no-hole 50 was not central in the cup.The involved cup was not used and another one was opened, same reference but different lot.
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Manufacturer Narrative
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On dec 15, 2017 the cq manager provided the report of the analysis performed on the retrieved cup with the following conclusion: the dimensional control has not identified any anomaly or defect.The device is conforming to the specifications.
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Search Alerts/Recalls
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