New etq record created in order to update etq (legacy system) complaint number wpc (b)(4).Reason for original complaint.Patient was revised to address a vertically.Malpositioned cup, with clunking and subluxation.Doi (b)(6) 2006 - dor (b)(6) 2012 (left hip).Update: (b)(4) 2013, pfs was received from legal, medical records were received from legal.There is no new information that would change the existing mdr decision.Records are available for further review.(b)(4) 2014 - x-rays received.X-rays may pertain to (b)(4).Update rec'd: (b)(4) 2014 - medical records received.Part/lot included.After review of the revision operative note it indicated metallosis so the liner and head are being reported.It also noted leg-length discrepancy so the stem and sleeve are being reported.There is no new additional information that would affect the existing mdr decision.The complaint was updated on: 3/10/2014.
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Litigation alleges friction and wear between the cobalt-chromium of the head and liner that caused large amounts of toxic metal ions and particles released into the blood, tissue and bone resulting to emotional distress, disfigurement, loss of mobility and loss of range of motion.
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Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.No device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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.Per nr-0134037 a medical record review is not required for this complaint record.Investigational inputs were requested as indicated per internal procedures for this failure mode.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Device history lot : null.Device history batch : null.Device history review : null.
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