Catalog Number UNK-HIP |
Device Problems
Naturally Worn (2988); Appropriate Term/Code Not Available (3191)
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Patient Problems
Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Pain (1994); Fibrosis (3167); No Code Available (3191)
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Event Date 04/20/2016 |
Event Type
Injury
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Manufacturer Narrative
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Additional narrative: 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.
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Event Description
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Litigation alleges patient was revised to address pain and elevated ions.
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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 the product and/or additional information be received, the investigation will be re-opened.
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Event Description
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Update may 16, 2017: legal medical records received.In addition to what was previously alleged, pfs alleges patient noticed a "bump" on his right hip with got bigger over time and experienced pain along with it.After review of medical records for mdr reportability it was reported that the patient was revised to address pain and dystrophic ossification.Preoperative lab confirmed elevated cobalt chromium levels and on the preoperative imaging revealed a large component of soft tissue disruption throughout the hip joint.Revision note reported a large mass was found to be present in the iliotibial band, it was incised and a large brownish fluid is present."clinical notes stated evidence of pseudotumor formation".In addition there was indication of minimal tendinosis and a large cystic changes around the acetabulum.Lab values for metal ions were below 7 ng/ml.There is no new information added that changes the existing mdr decision.This complaint was updated on: may 22, 2017.
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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.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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Event Description
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Ppf alleges metal wear and metallosis.
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Manufacturer Narrative
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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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Search Alerts/Recalls
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