Product complaint #: (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.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.An evaluation of the manufacturing record could not be performed as the required product/lot number was not provided to complete the evaluation.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 device lot number is unknown, therefore a device history review could not be performed. if the lot/serial number becomes available, the record will be re-assessed.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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In (b)(6) 2022, one month following the revision surgery due to the failed depuy asr prosthesis, the patient suffered an infection and inflammatory reaction requiring irrigation and debridement.Following the revision, the patient had pain in the area near the incision.From september 2022 to january 2023, the patient was also tested twice regarding his inflammation levels which the patient still has.The patient has been advised that his increased inflammation is not disease-related.Doi: (b)(6) 2009 (stem).Doi: (b)(6) 2022 (bi-mentum liner(2), cup, and head).Doe: (b)(6) 2022.Left hip.
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