Model Number 01.26.2839STT |
Device Problem
Output Problem (3005)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 07/04/2022 |
Event Type
Injury
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Manufacturer Narrative
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Batch review performed on 11-jul-2022: lot 101434: (b)(4) items manufactured and released on 08-jun-2010.Expiration date: 2015-04-30.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported case during the period of review.Preliminary investigation performed by r&d manager: looking at the images attached to the complaint the pe liner is visible.It is covered with patient blood, one hole is present on the spherical part done with the screw during revision surgery.Some sings and scratches are present on the liner surface probably due to revision surgery.Additionally one edge of the liner is broken probably due to revision surgery.More information will be added during visual inspection analysis if the part will be available.It is not possible to determine the root cause of reported worn of the inlay.
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Event Description
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The patient had a revision surgery due to decentration of the head (standard polyethylene liner).Primary surgery date unknown, lot released in 2010.
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Manufacturer Narrative
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The liner has been received on sep 30th 2022.Visual inspection performed by r&d project manager.From the analysis of the received piece, an internal eccentricity was noticed.Moreover, some damages were present on the liner due to the removal, both on the rim and on the internal surface.It is not possible to determine the root cause of the event, but this type of event is aligned with literature when standard polyethylene is used in acetabular components.
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Search Alerts/Recalls
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