Device Problems
Failure To Adhere Or Bond (1031); Material Deformation (2976)
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Patient Problems
Pain (1994); Arthralgia (2355); Limited Mobility Of The Implanted Joint (2671)
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Event Date 06/27/2016 |
Event Type
Injury
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Manufacturer Narrative
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This report will be amended when our investigation is complete.
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Event Description
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It was reported that a male patient was experiencing persistent pain in the right shoulder joint, osteoarthrosis, and instability.Patient x-rays confirmed dislocation.The patient underwent total right reverse shoulder arthroplasty due to dislocation of the reverse prosthesis.During revision surgery, the polyethylene component was noted to be loose sitting within the stem and had a large divot of defect within it.
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Manufacturer Narrative
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This report is being amended to reflect changes.No device or photos were received, therefore the condition of the device is unknown.Device history records cannot be reviewed since the lot number is unknown.This device is used for treatment.Product history search cannot be completed since the lot number is unknown.Surgical notes were not provided.It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.A definite root cause cannot be determined with the information provided.
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Manufacturer Narrative
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The root cause remains undetermined.
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Search Alerts/Recalls
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