This event involved 2 devices, same procedure, same patient.This is the 1st of 2 submissions.It was reported the surgeon could not snap the head onto the stem, the head popped off during surgery.It was reported, "i typically use the 1m position so there is less play for getting it in.I had to try 2 times to get it in, and i can only surmise that i may have deformed the poly edge getting it lined up before i clicked it together.However, that may be a bit of a stretch.It did not click very loudly or normally.Then later when we were ranging the elbow, we could see that it was loose.Used a second and all was fine.This one was a bit tight to put in." no patient injury was reported.
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This event involved 2 devices, same procedure, same patient.This is the 1st of 2 submissions.Mfr report numbers: 3004608878-2015-00290; 3004608878-2015-00291.Integra has completed their internal investigation on 2feb2016.The investigation activities included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: a review of the device history records determined that a quantity of (b)(4).Conclusion: based on the review of available documentation and the dimensional analysis, the probable root cause was that the polyethylene insert was deformed during the initial attempt to attach the radial head poly assembly to the radial head stem assembly.The damage increased the opening of the polyethylene insert, decreasing it¿s capability to retain the head of the radial head stem assembly under physiological load.The polyethylene insert is part of the device associated with report 3004608878-2015-00290.
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