Catalog Number 157002110 |
Device Problems
Unstable (1667); Failure to Align (2522); Migration (4003)
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Patient Problems
Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330)
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Event Date 05/21/2015 |
Event Type
Injury
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Manufacturer Narrative
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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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Aug 15, 2017: litigation records received.Litigation alleges discomfort, pain, stiffness, loss of motion, elevated cobalt-chromium metal ions, loosening, metallosis, necrosis, and soft tissue damage.No part and lot information provided.Update 24 aug 2017: pfs and medical records received.In addition to what was previously alleged, pfs alleges misalignment, limp, poor balance, and instability.After review of medical records, it was reported that the patient was revised to address subsidence.Updated part and lot information.There was no metallosis or necrosis mentioned in the revision notes.There were no laboratory values provided for the alleged elevated metal ions.This complaint was updated on: aug 29, 2017.
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Manufacturer Narrative
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No device associated with this report was received for examination.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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(b)(4).
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Event Description
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In addition to what were previously alleged, ppf alleges loosening of cup and metal wear.
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Manufacturer Narrative
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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.Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.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 will be filed as appropriate.
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Search Alerts/Recalls
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