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Zimmerbiomet complaint number (b)(4).The following sections have been updated: b4: date of this report.B5: describe event or problem.G3: date received by manufacturer.G8: type of report, follow-up number.H2: follow up type.H3: device evaluated by manufacturer: change ¿no' to 'yes'.H6: evaluation codes.H10: additional narrative.The complaint report was received, reviewed, and evaluated by the manufacturer's complaint process.Applicable manufacturer's lot history records were reviewed to evaluate whether any internal deviations, non-conformances, or problems occurred during the manufacture of the lot, which could cause or contribute to the reported complaint condition.A review of other manufacturer's complaint files and related trending data for similar incidents was performed to evaluate whether other similar complaints have been received and if data suggests any adverse trends may have contributed to the complaint root cause.Condition of the returned complaint related product was evaluated to confirm the reported product complaint.As part of each complaint investigation, the manufacturer performs an analysis to determine the root-cause of the reported problem.Depending upon the information provided, a true root-cause may or may not be determined.In these cases, the most-likely cause of the reported issue would be determined.Other known issues that are inherent to the business operations, typically ones that are related to shipping, handling, customer service, or other, are internally tracked and continually trended for unusual increases.As a result of the above investigation, the manufacturer has concluded the following as the root-cause or most likely root-cause of the reported complaint condition: as part of each complaint investigation, the manufacturer performs an analysis to determine the root-cause of the reported problem.Depending upon the information provided, a true root-cause may or may not be determined.In these cases, the most-likely cause of the reported issue would be determined.Other known issues that are inherent to the business operations, typically ones that are related to shipping, handling, customer service, or other, are internally tracked and continually trended for unusual increases.As a result of the above investigation, the manufacturer has concluded the following as the root-cause or most likely root-cause of the reported complaint condition.Most likely hazard experience:thread fracture during function.Most likely root cause of the failure mode / hazard: typically is the result from insufficient tightening torque at placement, overloading of the abutment in function, or not retightening the abutment at prescribed intervals.Known issue is being tracked and trended with no further actions taken at this time.
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