Catalog Number 151620805 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Swelling/ Edema (4577)
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Event Date 09/11/2014 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).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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Event Description
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Subject id: (b)(6); study no: (b)(6).Clinical adverse event received for effusion in right knee.Event is not serious and is considered mild.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2013, date of event: (b)(6) 2014, (right knee).Treatment: culture taken.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary :no device associated with this report was received for examination.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 records evaluation (mre) was not perform 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.
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Search Alerts/Recalls
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