SMITH & NEPHEW, INC. MI TRIAL FEM HEAD 32 +0; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 71369715 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/01/2020 |
Event Type
malfunction
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Event Description
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It was reported that the mechanism which holds the head to the trial neck broke off, rendering the head unusable.As noticed in the mdrd, no case was involved.
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Manufacturer Narrative
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The device, intended use in treatment, was not returned for evaluation, the reported event could not be confirmed.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.
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