(b)(4).Source: (b)(6).Source: g.Chatziagorou, h.Lindahl, j.Kärrholm.Surgical treatment of vancouver type b periprosthetic femoral fractures.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.(b)(4).
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It was reported in a journal article that study consisted of 1,381 operations that nineteen patients included in the study underwent a revision of femoral components with a b2 and b3 fracture.Further, one patient was noted to undergo a reoperation.Attempts have been made and additional information on the reported event is unavailable at this time.
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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, h10.Reported event was unable to be confirmed due to limited information received from the customer.Device history record 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.H3 other text : device not returned for evaluation.
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