Concomitant medical products and therapy date, detail of product: item number unknown, item name metasul ldh head, lot # unknown.Item number unknown, item name metasul ldh head adapter, lot # unknown.The manufacturer did not receive devices, x-rays, or other source documents for review, as the patient is currently being monitored and has not been revised to date.As no lot numbers were provided for the devices, the device history records could not be reviewed.The cause for this specific event cannot be ascertained from the information provided, as the patient has not been revised.The common clinical presentation and the date of the original implantation suggest that this case might be / is related to the issues for which zimmer implemented a notification in july 2008 as referenced above.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result is available, an amended medical device report will be submitted.Therefore, zimmer (b)(4) considers this case as closed.(b)(4).
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It was reported that patient underwent revision surgery due to pain, truninosis, periarticular inflammation, synovitis, metal wear debris with exaggerated biological reaction and rust colored joint effusion.
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