EXACTECH, INC. ALTEON 6.5MM SCREW, 25MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Model Number ALTEON 6.5MM SCREW, 25MM |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/10/2022 |
Event Type
malfunction
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Event Description
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As reported, during surgical use, basically doing a total hip on a patient, after placing the cup surgeon had issues getting the acetabular screws to sit down.Liner then wouldn¿t fully seat, after pulling the liner we could see indentations on it where the screws were pushing on it.He had to burn the liner and remove his screw fixation to get the liner to seat.Essentially had to abandon screw fixation to get a liner to seat.Once the screws were removed, the liner was able to be seated.There was no breakage of the device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Photos and images received.The device is not available for evaluation due to the devices were thrown away.
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Manufacturer Narrative
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Concomitant product: alt xle lnr ntrl g4 36 (cat# (b)(6)/ serial# (b)(6)).The intraoperative alteon screw seating difficulty reported was likely the result of the angle of the screws, which may have led to contact between the screws and the cup while inserting, preventing the screws from fully seating and leading to incomplete seating of the liner.However, this cannot be confirmed as the devices were not returned for evaluation.The most probable root cause associated with the reported event of "difficult to position¿ is associated with users experiencing difficulty or uneasiness to deploy a device, device component, or both, to a specified location.Furthermore, the most probable root cause associated with the reported event of "disassembled" is associated with the unwanted disassembly of the device, or incorrect assembly of the device (attaching mating instrumentation incorrectly, assembling an implant construct off-axis, etc.).
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Search Alerts/Recalls
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