(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2020-04190., 0001822565-2020-04192, 0001822565-2020-04193, 0001822565-2020-04194 concomitant medical products: distal femoral xt component size b left, item# 00585004201, lot# 64833183.Segment with male/female taper 40 mm length, item# 00585004604, lot# 64243509.Segment with male/male taper 80 mm length, item# 00585004808, lot# 63929410.Articular surface with segmental hinge post size b 12 mm height, item# 00585002012, lot# 64423658.Report source - (b)(6).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 report is being submitted to relay additional information.The following sections were updated: b4; b5; g4; g7; h1; h2; h3; h6.The reported event of deep infection <90 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.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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