The manufacturer did not receive devices or x-rays for review.Other source documents (surgical report) were provided.As no lot numbers were provided for the devices, the device history records could not be reviewed.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 as referenced.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result becomes available, that changes this assessment, an amended medical device report will be submitted.The need for further corrective measures is not indicated at this time.(b)(4).
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This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.D10: medical products: versys hip system femoral stem; catalog #: 6578821430; lot#: 60055789.Metasul ldh, head, 50, code p, taper 18/20; catalog #: 01.00181.500; lot#: 2382496.Metasul ldh, head adapter, s, -4, taper 12/14-18/20; catalog #: 01.00185.145; lot#: 2365318.Therapy date: (b)(6) 2018.This case was reopened on (b)(6) 2021 to enter additional information which had been received on jul 1, 2021.Additionals: a2, a3, d4, d6, d10, g4, h3, h6, h10.Updates: b5, d1, d2.Corrections: b4, g3, g6, h2.Since this case is related to the issues for which zimmer implemented a notification in july 2008 as referenced above in h7 and h9, zimmer switzerland manufacturing gmbh will close this case once again.Zimmer¿s reference number of this file is (b)(4).
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