Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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It was reported that on apr 1, 2013, the patient underwent the primary surgery via tha for oa for the right hip joint with the implants in question.The surgeon informed the sales rep that the patient had been hospitalized since late last year due to an anterior dislocation.The surgeon performed an mri scan, which confirmed the suspicion of trunnionosis.Revision surgery is scheduled for (b)(6) 2024.In addition, the cup used for the primary surgery was a competitor's no further information is available.
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