It was reported that there was an issue with biolox prosthesis head.According to the customer description, it was reported that the patient, who received total hip arthroplasty (tha) in 2003, was diagnosed with suspected ceramic liner breakage.The patient has difficulties in walking.A cup revision is scheduled on (b)(6) 2020.Details have not yet been provided.Infection : unknown.A revision surgery was necessary.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under (b)(4) reference (b)(4).Associated medwatch-reports: 9610612-2020-00195 ((b)(4) nj102); 9610612-2020-00196 ((b)(4) nh048t).
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