Catalog Number 999800315 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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Patient Problems
Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Unspecified Tissue Injury (4559)
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Event Date 04/14/2010 |
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.For any product information received.Complete product detail has not been received at this time.If further information is received a follow-up medwatch will be filed as appropriate.
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Event Description
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Litigation received alleging that the patient suffers pain, disability, and excessive levels of chromium cobalt.Update (b)(6) 2013 - plaintiff¿s preliminary disclosure form was received, which identified dob, doi, and part/lot information.The complaint and associated mdrs were updated.There was no new information that would change the outcome of the investigation.Update rec'd (b)(6) 2013 - ppd and medical records received.Dor is (b)(6) 2010.During the (b)(6) 2010 operation the femoral head and cup were revised for a pseudotumor.A competitor cup and poly liner were implanted and new depuy head was placed.There is no new additional information that would affect the existing mdr decision.The complaint was updated on: (b)(6) 2014.Update (b)(6) 2017.Pfs and medical records received.After the review of medical records for mdr reportability, it was stated that the patient was revised to address pain and pseudotumor growth from metal on metal articulation.Revision notes reported severe damage to all soft tissues and 50 cc of cloudy fluid with only 80 white cell count thought to be due to mom pseudotumor.There is no metal ion level information provided within the medical records.This complaint was updated on: (b)(6) 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 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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Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.The asr platform was voluntarily recalled from the market in (b)(6) 2010, and the asr product codes are now considered inactive.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.H10 additional narrative:.
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Search Alerts/Recalls
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