On (b)(6) 2023, the patient underwent a total left hip revision arthroplasty.Intraoperative findings included that the srom sleeve and stem were grossly loose at the bone-to-implant interface.Osteotomes and an oscillating saw were created to clear away extra bone to release the stem and sleeve.Subsidence was also identified which also caused a loss of leg length.The patient was converted to a dual mobility system but no allegations were noted against the original liner/head.Usfda determination: the patient was revised due to loosening of the stem and sleeve in the femoral bone.The stem/sleeve are being reported as they are what was noted to be grossly loose.The revision of the loose stem/sleeve led to subsidence, which then led to the leg length discrepancy, which caused the surgeon to convert to a dual mobility system the event description noted "no allegations were noted against the original liner/head.".There was also not allegations of deficiency noted for the cup and screws.Doi: (b)(6) 2016.Dor: (b)(6) 2023.Left hip.Please see (b)(4) for the first revision.
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Product complaint # (b)(4).H6 component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary : no device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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