Patient¿s previous proximal tibia replacement (2020), continuing to dislocate poly out of prox tibia component.Revision surgery demonstrated prox tibia replacement component was rotated, causing poly insert to dislocate from post.Also when removed, evidence of metal charring in the implant noted, which can lead to metalosis of components/tissue.Was surgery delayed due to the reported event? --> no, action taken when event occurred? --> replaced proximal tibia component, added segmental 25mm component , was procedure successfully completed? --> yes, were fragments generated? --> yes, if yes, were they removed easily without additional intervention? --> unknown, other information: --> metal wear noted , patient status/ outcome / consequences --> yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)?--> inflammation, dislocations, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> unknown, if yes, describe --> rotation of component in segmental sleeve caused repeated poly insert dislocations and potential metal breakdown , is the patient part of a clinical study --> unknown, ip-01474037 device property of -->none, device in possession of -->none by checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.--> true.
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Product complaint #(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Product complaint # (b)(4) investigation summary: the device associated with this device was returned for examination.The photo investigation and examination of the device found evidence of edge loading which confirmed the reported allegation.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: in order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional previous reports against the provided product code/lot code combination.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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