(b)(4).Concomitant medical products: persona cemented stemmed tibial component left size h, catalog #: 42532008301, lot #: 63659225.Persona cemented posterior stabilized standard femoral component left size 11, catalog #: 42500607001, lot #: 63792191.Persona all poly patella 38mm, catalog #: 42540000038, lot #: 63764241.The product was evaluated through manufacturing review and the complaint was confirmed through review of medical records.The device history records were reviewed and no discrepancies were identified.Per the persona knee system package insert, infection is a known potential adverse effect of this procedure.Single-use, sterilized devices manufactured or distributed by zimmer are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is highly unlikely that the specified device caused any patient infection.The medical records additionally state that the patient used a sewing needle to puncture one of the blisters around his incision site.While the presence of the blister indicates that an infection was likely already present, introducing a nonsterile object into or near the wound is highly likely to cause or contribute to infection.The root cause is considered to be a human factors issue.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.This report was previously submitted erroneously on jan 19, 2018 and nov 7, 2018 under manufacturing report number 0001822565-2018-00454.
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