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Device Problem
Malposition of Device (2616)
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Patient Problem
Joint Dislocation (2374)
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Event Date 01/12/2024 |
Event Type
Injury
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Event Description
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It was reported that a male patient, initial right shoulder implanted on an unknown date, underwent a revision surgery on january 12, 2024.The surgeon indicated that the original prosthesis subluxed on one occasion, before relocating itself without any need for a manipulation.The surgeon was reluctant to do anything due to it being an isolated event, however the patient was very insistent that something was done.During the revision, the poly and glenosphere were changed.There were no surgical delay or device breakages during the procedure.No x-rays were able to be obtained, and no explanted devices are available for return as the hospital was not willing to release them.No further information.
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Manufacturer Narrative
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Additional information, including the product investigation, will be submitted within 30 days of receipt.
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Manufacturer Narrative
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It was reported that a male patient, with an initial right shoulder implant on an unknown date, underwent a revision surgery on (b)(6) 2024.The surgeon indicated that the original prosthesis had subluxated on one occasion, and spontaneously relocated itself without any need for a manipulation.The surgeon was reluctant to do anything due to it being an isolated event, however the patient was very insistent that something be done.During the revision, the poly and glenosphere were changed.There was no surgical delay or device breakages during the procedure.No x-rays were available, and no explanted devices are available for return as the hospital is not willing to release them.No further information provided.
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Manufacturer Narrative
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H3: there is no device information provided.The cause of the patient¿s shoulder dislocation and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device-such as soft tissue imbalance, implant positioning, or activity level.The patient insisted that "something" be done.There is no mention from the reporter about device malfunction.Dislocation is a known device specific risk, outlined in the ifu.These devices are used for treatment not diagnosis.
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Search Alerts/Recalls
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