The product was returned for review.Visual examination found scratches on the lateral surface, an apparent guide pin puncture and very slight lateral indentions close to the articulation surface which is likely related to the removal of the device.The height and diameter of the device were within the post-sterilization value range.The patient was involved in a car accident a few years prior to implant removal.The accident could have been a contributing factor to the issues noted in this complaint, but a definitive root cause for the reported event cannot be identified.On november 10th, 2020 stryker trauma and extremities acquired cartiva, wright medical, tornier inc.And tornier sas.An effort was made to align the acquired entity complaint files with stryker's policies and procedures.Stryker has performed retrospective review of complaints and the reportability decision was revised to report this incident under the mdr/vigilance process.
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