(b)(4).Report source, foreign - event occurred in (b)(6).The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.
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(b)(4).No further information provided (x-rays, surgical report, photographs, lab test), therefore, the reported event could not be confirmed.The product analysis can't be performed as the product was not returned.The review of the device manufacturing quality can't be performed as the product reference and batch number was not communicated.A complaint extract was done regarding bone fracture: 1 complaint (1 product), this one included, has been recorded on uption complete femoral stem, from (b)(6) 2017 to (b)(6) 2020.- the complaint history, regarding the reference number, can't be performed as it was not communicated.The complaint history, regarding the batch number, can't be performed as it was not communicated according to available data, the most probable root cause of the bone fracture is the patient fall during the rehabilitation protocole.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.
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