WALDEMAR LINK GMBH & CO. KG ENDO MODEL M; ENDO-M. MOD.ROTATIONKNEE, TIBIAL COMP.,SMALL, NEUTRAL
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Model Number 15-2814/02 |
Device Problems
Separation Failure (2547); Difficult or Delayed Separation (4044)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/23/2024 |
Event Type
malfunction
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Event Description
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Dr.(b)(6) was using an endo model m tibial component (220808/2706) and one of the blind screws for attaching the augment could not be removed and the head got stripped.A second tibial component was opened and a new screwdriver was used but this also had one screw that was locked and could not be removed, leading to this screw head becoming stripped as well.The augment used was then cemented in place and the second tibial component was implanted.Surgery time was extended approximately 15 minutes.Note: the second tibial component is within the scope of recall r-2022-01, but the first tibial component which was opened, and displayed the same issue as the tibial components within the scope of that recall, was manufactured in dec 2022, and therefore is outside the scope of that recall.[customer].
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Event Description
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Dr.(b)(6) was using an endo model m tibial component (b)(6) and one of the blind screws for attaching the augment could not be removed and the head got stripped.A second tibial component was opened and a new screwdriver was used but this also had one screw that was locked and could not be removed, leading to this screw head becoming stripped as well.The augment used was then cemented in place and the second tibial component was implanted.Surgery time was extended approximately 15 minutes.Note: the second tibial component is within the scope of recall r-2022-01, but the first tibial component which was opened, and displayed the same issue as the tibial components within the scope of that recall, was manufactured in dec 2022, and therefore is outside the scope of that recall.[customer].
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Manufacturer Narrative
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This is the final supplemental report, the complaint is closed.
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Search Alerts/Recalls
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