Catalog Number 136508100 |
Device Problems
Corroded (1131); Metal Shedding Debris (1804); Device Dislodged or Dislocated (2923); Naturally Worn (2988); Appropriate Term/Code Not Available (3191)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032); Weakness (2145); Injury (2348); Joint Dislocation (2374)
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Event Date 10/20/2017 |
Event Type
Injury
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Manufacturer Narrative
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This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
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Event Description
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Litigation record received.Litigation alleges corrosion and friction wear, toxic cobalt-chromium metal debris, pain and difficulty with the implant.There is no report of revision at this time.
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Manufacturer Narrative
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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 no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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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Manufacturer Narrative
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(b)(4).
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Event Description
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Pfs and medical records received.Pfs alleges physical injuries, pain, altered gait, loss in range of motion, weakness in hips, leg weakness, metallosis and muscle loss.After the review of medical records for mdr reportability, there is no revision information provided for the left hip.
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Manufacturer Narrative
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(b)(4).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.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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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.
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Event Description
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Ppf alleges dislocation, metal wear and metallosis, however metal wear and metallosis were already reported.
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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. udi: (b)(4).
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Search Alerts/Recalls
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