Catalog Number 121703052 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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Patient Problems
Pain (1994); Joint Swelling (2356); Limited Mobility Of The Implanted Joint (2671)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Litigation received.Litigation alleges pain, suffering, and emotional distress.Update 5/25/2016: pfs and medical records received.Pfs and medical records reviewed fro mdr reportability.Pfs reported no revision surgery and severe pain, barely able to walk, swelling of limb and uses a cane to walk.Stem, cup and hole eliminator added to complaint.Part/lot updated.The complaint was updated on: jun 13, 2016.
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Manufacturer Narrative
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No device associated with this report was received for examination.A worldwide complaint database search found no other related incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.The reported event is considered one of the possible complications of joint replacement.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device history lot : null.Device history batch : null.Device history review : null.
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Manufacturer Narrative
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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.Product complaint # : (b)(4).Investigation summary : 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.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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