Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly related to the event.The following sections could not be completed due to the part/lot information could be: catalog number - 180550, lot number - 521430, expiration date ¿ june 30, 2024 , pma/510(k) number - k080642, manufacture date ¿ june 12, 2014.Or the part/lot information could be: catalog number -180552, lot number - 309170, expiration date - november 30, 2024, pma/510(k) number - k080642, manufacture date ¿ november 13, 2014.Or the part/lot information could be: catalog number -180560, lot number - 438920, expiration date - november 30, 2023, pma/510(k) number - k080642, manufacture date ¿ december 3, 2013.Or the part/lot information could be: catalog number -180563, lot number - 027190, expiration date - october 31, 2023, pma/510(k) number - k080642, manufacture date ¿ october 27, 2014.Or the part/lot information could be: catalog number - 115395, lot number - 402790, expiration date - august 31, 2024, pma/510(k) number ¿ k113121, manufacture date ¿ august 22, 2014.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: "improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components.".
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