EXACTECH, INC. 0 STD RIGHT TRAY; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
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Model Number 0 STD RIGHT TRAY |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/05/2024 |
Event Type
malfunction
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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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Event Description
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As reported, during implantation of the standard right +0 hat humeral tray within the two small inferior holes on the implant a plastic or poly material was inside the hole.The surgeon was the one who recognized the plastic material.He confirmed that this material was not cement.The staff used a k-wire to dig a small portion out.Then, the staff finalized the process of implanting.There was no breakage of device or surgical delay/prolongation.Images received.Sales rep was unable to obtain x-rays.The device is not available for evaluation due to the device was implanted.
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