Catalog Number 01.26.2848M |
Device Problem
Material Deformation (2976)
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Patient Problem
Pain (1994)
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Event Date 07/08/2018 |
Event Type
Injury
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Manufacturer Narrative
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Batch review performed on 17 august 2018.Lot 147751: (b)(4) items manufactured and released on 19 january 2015 expiration date: 2019-11-30 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.Clinical evaluation performed by medical affairs director: premature liner wear in a double mobility cemented cup 3 years after implantation.Index surgery was a revision thr for recurrent dislocation.The significant osteolysis visible in the proximal femur could be a consequence to the macroscopic wear.The cause for wear cannot be determined with the available information; one possible hypothesis is the secondary presence of cement particles in the articulation.Component analysis may supply further information.
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Event Description
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The patient complained hip pain 3 years after the previous surgery.The surgeon revised successfully the liner and the head.A premature liner wear and deformation was detected.
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Manufacturer Narrative
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Visual inspection performed by r&d project manager on 20 september 2018 the dual-mobility pe liner shows important material erosion with respect to the original shape.The pe loss seems due to third body wear or to repeated contact and friction with abnormal third body.Few light shining debris are visible inside the scratches in the pe liner, when exposed to bright light.Microscopic analysis reveals black particles on the pe liner outer surface.It might be assumed that these are metal debris.No other debris of other nature were found on the liner.Femoral head shows few metal-transfer signs and huge metal-transfer area.It is not possible to determine failure root cause.At the time of revision surgeon reports no metallosis in the patient and a perfect status of shell and stem.
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Search Alerts/Recalls
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