This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states.Concomitant medical products: durom us acet cmpnt 54/48 n; catalog#: 01.00214.154; lot#: 2423579, metasul ldh, head adapter, s, -4, taper 12/14-18/20; catalog#: 01.00185.145; lot#: 2421995, femoral stem press-fit collarless 12/14 neck taper standard body extended neck offset size 14 149 mm stem length cementless; catalog#: 00-7864-014-20; lot#: 60892889.Therapy date: (b)(6) 2019.The manufacturer received x-rays and other source documents for review.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.While a cause for this specific event cannot be ascertained from the information provided, the common clinical presentation and the date of the original implantation suggest that this case is related to the issues for which zimmer implemented a notification in july 2008.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Therefore, zimmer (b)(4) considers this case as closed.Zimmers reference number of this file is (b)(4).
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Patient was implanted with a durom cup on the left side and underwent a revision surgery due to pain, metallosis, elevated metal ion levels, decreased activity of daily living, corrosion and adverse local tissue reaction.
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