(b)(4).Concomitant medical products: 650-1064 ¿ ceramic taper ¿ 3064989, 650-1055 ¿ ceramic head ¿ 2020011173, 47249009700 ¿ tear drop guide wire ¿ 65316177, 166069 ¿ arcos screw ¿ 6828663, 166069 ¿ arcos screw ¿ 7032015, 166070 ¿ arcos screw ¿ 6970413, 166068 ¿ arcos screw ¿ 7053131, 166067 ¿ arcos screw ¿ 7197916.Report source australia.Product will not be returned to zimmer biomet for the investigation as the product was discarded.The investigation is in process.Once the investigation as been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 00091, 0001825034 - 2023 - 00092, 0001825034 - 2023 - 00093, 0001825034 - 2023 - 00095, 0001825034 - 2023 - 00096, 0001825034 - 2023 - 00097, 0001825034 - 2023 - 00098.
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This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A radiograph was provided and reviewed by a health care professional.As the complaint is infection related the x-ray did not enhance the investigation.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.No device problem was found.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, 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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