(b)(4).Report source foreign: (b)(6).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be determined.Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards to a sterility assurance level.Therefore, it is unlikely that the specified device caused any patient 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 00672, 0001825034 - 2022 - 00673, 0001825034 - 2022 - 00674.
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It was reported that approximately ten (10) days after hip implant surgery, a few colonies of mild staphylococcus epidermidis infection were detected on the skin close to the wound.Patient¿s surgical wounds were cleaned with povidone iodine.This was not a surgery.This was not done in the operating room, it¿s just a dry clear of the wound.Event got resolved after this intervention.No other complications reported.No further event information available at the time of this report.
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