Catalog Number UNK-HIP |
Device Problems
Naturally Worn (2988); Insufficient Information (3190)
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Patient Problems
Abscess (1690); Foreign Body Reaction (1868); Necrosis (1971); Pain (1994); Scarring (2061); Synovitis (2094); Discomfort (2330); No Code Available (3191)
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Event Date 03/30/2015 |
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.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.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 alleges patient was revised to address pain and discomfort.
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Manufacturer Narrative
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Examination of the reported devices was not possible as they were not returned.A search of the complaints databases and/or a review of device history records were not possible as the required product/lot code combinations were not provided.The investigation can draw no conclusion regarding the reported event with the information available.Based on the inability to determine root cause, the need for corrective action has not been indicated.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.
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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.Additional narrative: udi: (b)(4).Patient code: no code available (3191) used to capture blood heavy metal increased.
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Event Description
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Ppf alleges metal wear, metallosis, and elevated metal ions.After review of medical records, patient was revised to address symptomatic metal-on-metal hip on the left.Revision notes stated of scarring between the it band and significant synovitis was encountered most immediately upon trying to remove the external retractors, which were adhered down to the capsule.There was dark reaction in the tissues, although not near as extensive as her contralateral side where she had formation of aseptic abcess.This appeared to be in earlier stages with primarily extensive synovial changes noted and deposit of the black debris in the synovium.The cup was noted to have necrotic material between the liner and the acetabulum.
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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.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 will be filed as appropriate.
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Search Alerts/Recalls
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