(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been discarded.Associated products: medical product: unknown oxford tibia, catalog no.: unknown, lot no.: unknown.Medical product: unknown oxford femoral, catalog no.: unknown, lot no.: unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device discarded.
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Cmp-(b)(4).Complaint summary: the event reports the implant fractured which resulted in revision surgery.The exact length of time the implant was in situ is unknown, but it was reported to be approximately 10 years.Product has not been returned for evaluation.The item and lot number have not been provided.X-rays or medical notes have not been provided.The investigation has been limited to the information provided.A historical search could not be performed as the item and lot number have not been provided.This device is used for treatment.Not enough information has been provided to determine if all implants are compatible.A dhr review or a review of recalls could not be performed as the item and lot number have not been provided.The likely condition of the device when it/ left zimmer biomet could not be determined as the item and lot number has not been provided.The root cause of the reported event cannot be determined with the information provided no corrective action required at this time as the root cause of the reported event has not been determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.
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