(b)(4).Event occurred in (b)(6).The following could not be completed with the limited information provided.Date of event - ni, expiration date - ni, date implanted - ni, date explanted - ni, manufacture date - ni.It has been indicated that the product will not be returned to zimmer biomet, as its location is unknown.Reported event was unable to be confirmed due to limited information received from the customer.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.Palomäki, a., lempainen, l., matilainen, m., eskelinen, a., remes, v., virolainen, p., mäkelä, k.T.(2017).Survival of uncemented cups from a single manufacturer implanted from 1985 to 2103: finnish arthroplasty register data.Archives of orthopaedic and trauma surgery, 137, 311-320.
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