SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
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Model Number R3 20 DEG XLPE ACET LNR 32MM X 48MM |
Device Problem
Compatibility Problem (2960)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/25/2020 |
Event Type
Injury
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Event Description
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It was reported that after thr procedure, on (b)(6), it was found that the inner liner was suspected to fall off.On (b)(6), during the revision surgery, it was confirmed that the r3 20 deg xlpe acet lnr 32mm x 48mm fell off and was replaced with a new one.The current health state of the patient is good.
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Manufacturer Narrative
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It was reported that a revision surgery was performed due to device suspected to be falling off.The associated r3 20 deg xlpe acetabular liner, used in treatment, was returned and evaluated.A visual inspection of the device shows the device is severely damaged probably during explantation.Dimensional analysis could not be performed with accuracy due to the damage.A review of manufacturing records did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.This reported migration has been identified in the instructions for use and risk management files as potential adverse events.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.A clinical analysis noted that the implantation surgical plan was provided along with an intraoperative picture, pictures of the liner and x-rays.The provided information did not reveal the root cause of the liner migration.It was reported that the current health of the patient is good.Some potential causes of the reported event could include but are not limited to traumatic injury, patient anatomy or size of device.
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