SMITH & NEPHEW, INC. ANTHOLOGY STD BROACH SIZE 7; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Model Number 71365607 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Injury (2348)
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Event Date 01/22/2020 |
Event Type
Injury
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Event Description
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It was reported that during a thr procedure, the size 7 broach went deeper down the femur than the size 6.No sign of fracture.The surgeon thinks the broach may be defective.No delays reported.A backup device was available.
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Manufacturer Narrative
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The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that no relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's current condition is unknown.Therefore based on insufficient information, a thorough clinical assessment cannot be performed at this time.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 have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes of this event could include improper device size used or a procedural error.
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Search Alerts/Recalls
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