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Model Number N/A |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Pain (1994); Swelling (2091)
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Event Date 08/03/2016 |
Event Type
Injury
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state this type of event can occur: under possible adverse effects, number 10 states, "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity." number 20 states, "persistent pain." implant date - during 2014.
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Event Description
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Patient's right knee was revised approximately 2 years post-implantation due to pain, swelling, and loosening of the tibial component.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was not confirmed.The tibial tray shows evidence of burnishing on the fixation surface, which is indicative of the loosening of the tibial implant that was reported as the reason for revision.The presence of burnishing of the metal suggests that it was loose from the cement, as opposed to the cement being loose from the bone, although radiographs and the return of the cement mantle may help to confirm this.This may imply sub-optimal cementing of the tibial tray or that the tray was not clean and dry prior to the application of cement.It is also possible that the cement was left to cure for longer than optimal, resulting in reduced cohesion to the tray.The absence of radiographs or surgical reports prevents any assessment of implant position and selection.Information on the patient¿s height, weight and typical activity level have also not been made available.Therefore, the influence of such factors on the ultimate cause for revision cannot be determined.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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