SMITH & NEPHEW, INC. ANTHOLOGY SO TR NECK SZ 1-6; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Model Number 71365701 |
Device Problem
Material Disintegration (1177)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/14/2020 |
Event Type
malfunction
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Event Description
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It was reported during the procedure, thr, that the coating on trial necks wear off, causing that the magnet detaches from the trial neck.The procedure was completed without delay, using the same device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.A visual inspection of the returned device confirmed the stated failure mode.The coating on the magnet is no longer visible rendering the device inoperable.The device was manufactured in 2012 and shows signs of extensive use.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.
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