Catalog Number 5532-G-411 |
Device Problems
Difficult to Insert (1316); Material Deformation (2976)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/23/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
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Event Description
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As reported: "patient had primary total knee arthroplasty implanting size 4 x 11 ps tibial bearing insert into size 4 universal baseplate, after using tibial insert impactor to fully seat insert, noticed locking wire had been partially dislodged from the insert not allowing insert to fully seat in baseplate.Doctor stated that he believed first insert was defective.Doctor asked for new insert which was available and implanted new insert without issue.".
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Manufacturer Narrative
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An event regarding a seating/locking issue involving a triathlon insert was reported.The event was not confirmed.Conclusion: the exact cause of the event could not be determined with the provided information.Results from material analysis stated that damage observed on anterior surface of the insert at the location of the locking wire.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Since the product was returned damaged dimensional and functional could not be performed.Thus the root cause of this event could not be determined.A trend analysis was conducted for the reported failure mode and concluded that seating/locking difficulties may arise from user-related issues associated with the preparation of the joint space prior to the attempted seating and with the technique required to correctly introduce the insert component to the baseplate.No further investigation for this event is required at this time.
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Event Description
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As reported: "patient had primary total knee arthroplasty implanting size 4 x 11 ps tibial bearing insert into size 4 universal baseplate, after using tibial insert impactor to fully seat insert, noticed locking wire had been partially dislodged from the insert not allowing insert to fully seat in baseplate.Doctor stated that he believed first insert was defective.Doctor asked for new insert which was available and implanted new insert without issue.".
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Search Alerts/Recalls
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