SMITH & NEPHEW, INC. REF THREE HOLE SHELL 60MM; PROSTHESIS,HIP,SEMI-CONSTRAINED,UNCEMENTED,METAL/POLYMER,POROUS
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Model Number 71336460 |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/04/2019 |
Event Type
malfunction
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Event Description
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It was reported that during surgery, cup and corresponding liner did not fit properly.It is unknown how the procedure was concluded or if there was a delay.No injury reported.
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Manufacturer Narrative
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Additional information:event.
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Event Description
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It was reported that during surgery, cup and corresponding liner did not fit properly.Procedure was postponed since a backup device was not available.
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Manufacturer Narrative
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The associated complaint devices were not returned.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incidents.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.Without the actual products involved and/or device information, our investigation cannot proceed.If the devices or new information is received in the future, these complaints can be re-opened.No further actions are being taken at this time.
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Manufacturer Narrative
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The associated devices, used in treatment, were returned and evaluated.A visual inspection of the returned devices could not confirm the stated failure mode.The devices have some signs of damage from implantation / insertion / extraction.The devices were manufactured in 2018 and 2019.A dimensional inspection of the shell found it to be within specification.A review of complaint history did not reveal additional complaints for the listed batches.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 have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes of the reported event could include improper insertion technique or device damaged during insertion.Based on this investigation, the need for corrective action is not indicated.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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