Catalog Number UNK HIP FEMORAL HEAD METAL ASR |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Ossification (1428); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Renal Failure (2041); Anxiety (2328); Distress (2329); Discomfort (2330); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)
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Event Date 03/31/2021 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.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.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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Asr litigation record received.Patient alleges pain, discomfort, elevated metal ion, permanent injuries, emotional distress, disability, disfigurement,and patient's ability to perform normal and enjoy regular activities has been impaired.Doi: (b)(6) 2009 - dor: (b)(6) 2021 (right hip).
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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.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.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 : device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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In addition to previous allegation pfs alleges limited mobility, adl, anxiety 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.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.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 : device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.
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Manufacturer Narrative
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Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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Medical records received: after a review of the medical records, the patient was revised to address elevated metal ions, discomfort, chronic kidney disease, hip and back pain, dysfunction, and limited mobility.Operative note reported some heterotopic ossification, upon opening the joint there was a black liquid sludge came out with typical sign of metallosis and wear in the hip.There was some small amount of notching in the femoral neck in the superolateral aspect.Asr cup, head and sleeve were revised.Re-implanted with 66 multi-hole redapt modular cup (competitor), 52 polyethylene ball from the smith & nephew competitor and 1.5 titanium sleeved 28 diameter biolox delta ceramic (depuy).Summit stem was unrevised.There was no further information provided post-revision or any complication.Right hip.
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Search Alerts/Recalls
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