SMITH & NEPHEW, INC. REF SPHER HEAD SCREW 30MM; PRSTHSIS,HIP,SMI-CNSTRND,UNCMNTD,METAL/POLYMR,NON-PORS,CALICUM-PHSPHTE
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Catalog Number 71332530 |
Device Problems
Calibration Problem (2890); Unintended Movement (3026)
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Patient Problems
No Consequences Or Impact To Patient (2199); Injury (2348)
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Event Date 01/02/2019 |
Event Type
malfunction
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Event Description
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It was reported that after a total hip replacement procedure, post operative film showed that the screw had gone completely through the shell.No delay reported.No revision surgery performed.
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Manufacturer Narrative
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The associated complaint devices were not returned.A clinical evaluation was conducted and based on the information provided the root cause of the acetabular screw penetration cannot be definitively determined, the device remains implanted.The patient impact cannot be completed as it is unknown if migration could occur or migration of the shell at this time.No further medical assessment can be rendered at this time.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.
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Manufacturer Narrative
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Information was received that changed the type of incident to a malfunction.Post op film showed that the screw had gone completely through the shell with no direct impact to the patient.
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Search Alerts/Recalls
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