(b)(4).Report source, foreign: event occurred in (b)(6).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a supplemental mdr will be submitted.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
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(b)(4).This final/follow-up report is being submitted to relay additional information.G3: report source, foreign - event occurred in switzerland.D10: product has been returned to zimmer biomet for investigation the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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(b)(4).This final report is being submitted to relay additional information.G3: report source, foreign - event occurred in switzerland.A right oxford anatomic bearing was revised due to fracture after approximately 12 years and 7 months in vivo.The oxford bearing was received split in two fragments, thus confirming the reported cause of revision.The relevant manufacturing history records indicate that the parts were manufactured and sterilised in accordance with the applicable specifications.Visual examination and measurements of the fragments indicated extensive damage of the superior articulating surface of the bearing, with the thickness of the central region of the component being 2.65 mm below its nominal thickness.Further information such as patient information, radiographs and surgical notes are required to confirm the root cause of the component fracture.However, high wear due to third body debris and embrittlement due to induced oxidation likely contributed to the failure.The mhr review indicates that the product was most likely conforming to design specification when it left zimmer biomet control, and the likely failure mode is wear due to third body debris and embrittlement due to induced oxidation.Risk assessment: failure analysis report: a right oxford anatomic bearing was revised due to fracture after approximately 12 years and 7 months in use.The femoral and tibial components are presumed to have been left in vivo.The polyethylene bearing was received split in two fragments, both presenting extensive wear and material loss from the superior articulating surface.This was confirmed by measurements compared with the dimensions specified on the relevant engineering drawing.The root cause of the bearing wear and fracture could not be determined in this instance with the available information.However, high wear due to third body debris and embrittlement due to induced oxidation likely contributed to the failure.The reported event states revision surgery due to implant fracture.The severity score is 3, which is defined in the rmr as: prescribed medical or surgical intervention to preclude permanent impairment of a body function or body structure.Contributed to minor, temporary, or medically reversible injury.Therefore, the reported event is considered to be within the severity of the rmr.In order to calculate the occurrence rate, sales and complaint data for this item number have been obtained, and are attached for a period of the last 3 calendar years prior to notification date, being oct 2019.Sales (oct 2016 ¿ oct 2019 inclusive) = (b)(4) units.Complaints search was conducted for events occurring between oct 2016 ¿ oct 2019 for item 159569.Three complaints were identified for this item number including (b)(4).Therefore, the calculated occurrence rate is (b)(4) or (b)(4).This is considered an acceptable occurrence rate as per the rmf ((b)(4) is considered an occurrence score of 3 occasional:(b)(4) 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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