(b)(4).This is a combined initial/final report and is being submitted to relay information.Report source, foreign - event occurred in (b)(6).The product will not be returned to zimmer biomet for an investigation as the product location is unknown.Medical product: unknown oxford bearing component, catalog #: unknown, lot #: unknown medical product: unknown oxford tibial component, catalog #: unknown, lot #: unknown multiple mdr reports were filed for this event, please see associated reports: 3002806535-2022-00118 and 3002806535-2022-00120.Complaint summary: product has not been returned for evaluation.The item and lot number have not been provided.X-rays or medical notes have not been provided.The investigation has been limited to the information provided.A historical search could not be performed as the item and lot number have not been provided.This device is used for treatment.Not enough information has been provided to determine if all implants are compatible.A dhr review or a review of recalls could not be performed as the item and lot number have not been provided.Unable to perform previous field action search as item and lot number have not been provided.The likely condition of the device when it left zimmer biomet could not be determined as the item and lot number has not been provided.The root cause of the reported event can not be determined with the information provided.
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Title: cemented medial mobile-bearing unicompartmental knee arthroplasty: effects of compliance with current indications on functional outcomes and long-term survival rates authors: luis bernal-fortich, md, andr_es correa-valderrama, md, andres echeverry-v_elez, md, willy stangl-herrera, md, erika cantor, msc, monica morales, msc, julio cesar palacio-villegas.Published on 31 december 2020.On 14 sep 2021, a journal article was retrieved by our clinical team from the journal of arthroscopy and joint surgery that reported a study from colombia.The objective of this study was to describe the functional outcomes and long-term survival rates of cemented medial mobilebearing uka according to the compliance with current indications.This was a retrospective study of 78 patients with medial unicompartimental knee oa treated with mobile-bearing cemented uka (oxford phase-iii) between 2002 and 2012, with an average follow-up of 10.4 ± 3.4 years.When proper patient selection is carried out, cemented medial mobile-bearing uka offers good functional outcomes with a survival rate of 89.7% at 15 years of follow-up the study reports revision due to periprosthetic joint infection in one patient.
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