(b)(4).No device or photos were received; therefore the condition of the component is unknown.Device history records cannot be reviewed since the part and lot number is unknown.This device is used for treatment.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.It is noted in the article that ¿one humeral component with inadequate cementation was found to be loose 4 years postoperatively¿.Follow up communication with the field and the article indicates that ¿an anterograde cementing technique was used with direct injection of the cement with a syringe, contrary to the recommendations of the manufacturer, which advises the use of an injecting system with retrograde insertion of the cement.¿ the follow up communication also states that the ¿early loosening described in the article were all related to the anterograde cementing technique which did not correspond to the recommended injecting system with retrograde insertion¿.Product history search cannot be completed and the compatibility cannot be verified since the part and lot number is unknown.Patient activity level and adherence to rehabilitation protocol is unknown.The bone cement information is unknown and therefore manufacturer¿s cementing technique cannot be compared with the cementing technique given in the article.A definite root cause for the loosening cannot be determined with the information provided.
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