(b)(4).List of associated devices: avantage cup, reference and batch not communicated; 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).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 medical reaction: 12 complaints (12 products), this one included, have been recorded on exception stem, from (b)(6) 2018 to (b)(6) 2021.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, root cause of the event was unable to be determined.However, there is no evidence that the event is related to the product.A summary of the investigation has been sent to the customer.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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