Information was received via published literature.(b)(4).Other device used: catalog # unknown, unknown zimmer tm reverse polyethylene liner, lot # unknown.Catalog # unknown, unknown zimmer tm reverse base plate, lot # unknown.Please reference literature at the following location: http://www.Ncbi.Nlm.Nih.Gov/pmc/articles/pmc4168654/ operative notes were requested; however, none provided.Relevant medical history and adherence to rehabilitation protocol are unknown.No devices or photos were received; therefore, the condition of the components is unknown.The part and lot numbers of the product are unknown; therefore, the device history records could not be reviewed.The complaint history for these products could not be reviewed due to the lack of lot numbers.It could not be confirmed if the devices are an approved and compatible combination.A definitive root cause cannot be determined with the information provided.The investigation could not verify or identify any evidence of product contribution to the reported problem.Based on the available information, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.Zimmer, inc.Considers the investigation closed.
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It has been reported that 16 patients had scapular notching.Of these, 7 patients had grade 1 scapular notching, 7 patients had grade 2 notching, 1 had grade 3 and 1 had grade 4 notching.
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