(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2020-02902.0001825034-2020-02904.Medical product: vngd ps tib brg 10x71/75mm item# 183640 lot# 040510.Van ps open intl fem-lt 70 item# 183132 lot# j3880066.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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This follow-up is being submitted to relay additional information.Updated: b4, b5, d4, g4, g7, h1, h2, h3, h4, h6, and h10 the reported event of deep infection greater than ninety days occurred post implantation.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.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.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, therefore implanted products are not identified as the source or contributing to the reported infection.Noted events of tibial component loosening, blood loss and postop anemia are all secondary to the infection, as noted by the surgeon in the medical records.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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