Product complaint # : (b)(4).Investigation summary : the device associated with this complaint was received for examination.The photo investigation and visual examination of the returned device confirmed the reported allegation.The device was found broken.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : a manufacturing record evaluation was performed for the finished device , and no non-conformances / manufacturing irregularities were identified.Device history review = > a manufacturing record evaluation was performed for the finished device , and no non-conformances / manufacturing irregularities were identified.
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Additional information received: a.Patient demographics the following are the types of patient demographics we require: relevant comorbidities, date of implantation (b)(6) 2018, date of revision (b)(6) 2022, operative side right, age at the time of the procedure 65, weight 120 kg, height 1,80m, and activity level.Active.B.Excerpts from the clinical correspondence: please provide all correspondence relevant to the reported event for example: onset of symptoms, trauma, other devices, leg length discrepancy, gait patterns, medical investigations or any other issues the complainant feels important.The only thing we know is that the patient fell.
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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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