Cmp (b)(4).D10: 110010262 item name g7 osseoti multihole 48mm c lot # unknown.110024461 item name g7 dual mobility liner 38mm c lot # unknown.22-301323 arcos con sz c std 70mm ha lot # unknown.22-300916 item name arcos 16x190mm spl tpr dist ha lot # unknown.G2: foreign: spain.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 02249 0001825034 - 2023 - 02250 0001825034 - 2023 - 02252 0001825034 - 2023 - 02253 the device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted h3 other text : device remains implanted.
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This follow-up report is being submitted to relay additional information.A seroma is a pocket of clear serous fluid that sometimes develops in the body after surgery.This fluid is composed of blood plasma that has seeped out of ruptured small blood vessels and inflammatory fluid produced by the injured and dying cells.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbidities, and perioperative management.Superficial infections are considered a procedure related complication as no device has been reported as revised.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.During the investigation process a review of the sterile certifications were not reviewed, as no product part/lot information was provided.All devices manufactured follow acceptable sterilization processes according to published iso/aami/astm & eu guidelines.A superficial infection was reported and no product information was provided; therefore, validation of sterile certifications cannot be performed.However, the reported event is considered procedure related.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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