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Catalog Number 2-1001 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Swelling/ Edema (4577)
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Event Date 03/13/2024 |
Event Type
Injury
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Manufacturer Narrative
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This event is being reported due to the device removal scheduled as a result of the device malfunction.Once explanted and returned, and the investigation is completed, a follow-up report will be submitted.
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Event Description
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Clinical trial patient in europe experienced a cracking sound and felt clicking.On examination, the patient had swelling/hydrops, retropatellar crepitations during mobilization.Knee remains stable with full range of motion.X-ray showed device malfunction.Device removal is scheduled.
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Manufacturer Narrative
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This supplemental report is being provided due to the device removal which took place after the initial report of device malfunction was submitted.An update on the investigation is also being provided.A review of manufacturing records indicates that the product conformed to design and manufacturing specifications.The device was returned, and the malfunction was confirmed on analysis.A sudden giving way of the knee may lead to instability, potential falls and possible distortion of the knee into non physiological positions.The knee was and remains stable.The knee giving way events are likely associated with the presence of knee oa or weak quadriceps.Given the temporal proximity of the knee giving way and subsequent sensation of device clicking, it is reasonable to link the giving way event as a cause of the malfunction.
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Event Description
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This supplemental report is being provided due to the device removal which took place after the initial report of device malfunction was submitted.Clinical trial patient in europe experienced an episode of the knee giving way, cracking sound and felt clicking.On examination, the patient had swelling/hydrops, retropatellar crepitations during mobilization, no medial/lateral or ap knee instability and full range of motion.X-ray showed device malfunction.The patient reported knee giving way experiences prior to and after device implantation, and immediately preceding the event.Device was removed approximately a month later.The event resolved, patient reported to be doing well with slight medial swelling and full range of motion.
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Search Alerts/Recalls
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